Trump admin. funds plasma company based in owner’s condo

WASHINGTON (AP) — An obscure South Carolina company may be in line for millions of dollars in U.S. government funding to produce a coronavirus treatment after a former Republican senator with a financial stake in the business lobbied senior U.S. government officials.

Plasma Technologies LLC, has received seed money to test a possible COVID-19-fighting blood plasma technology. But as much as $65 million more could be on the way, a windfall for the company that operates out of the founder’s luxury condo, according to internal government records and other documents obtained by The Associated Press.

The story of how a tiny business, which exists only on paper, has managed to snare so much top-level attention is emblematic of the Trump administration’s frenetic response to the coronavirus pandemic.

And it’s another in a series of contracts awarded despite concerns over their proposals voiced by government scientists. The others include an $21 million study of the heartburn drug Pepcid as a COVID therapy, and more than a half-billion dollars to ApiJect Systems America, a startup with an unapproved medicine injection technology and no factory to manufacture the devices. In addition, a government whistleblower claimed that a $1.6 billion vaccine contract to Novavax Inc. was made over objections of scientific staff.

At the center of these deals is Dr. Robert Kadlec, a senior Trump appointee at the Department of the Health and Human Services, who backed the Pepcid, Novavax and ApiJect projects. Records obtained by the AP also describe Kadlec as a key supporter of Plasma Tech, owned by Eugene Zurlo, a former pharmaceutical industry executive and well-connected Republican donor. Three years ago, Zurlo brought Rick Santorum, who spent 12 years as a GOP senator from Pennsylvania, aboard as a part-owner.

Kadlec has come under pressure from the White House to act with more urgency and not be bound by lower-level science officials whom Trump has castigated as the “deep state” and accused of politically motivated delays in fielding COVID-19 vaccines and remedies.

The AP reached out to more than a dozen blood plasma industry leaders and medical experts. Few had heard of Zurlo’s company or its technology for turning human plasma into protein-rich antibody therapies, and would not comment.

Zurlo said in an email that the shortage of plasma from recovered COVID-19 patients, which is needed to make these therapies, underlines the need for the technology he’s patented to harvest as many of these proteins as possible.

In early April, shortly after Congress supplied hundreds of billions of dollars to combat the pandemic, Santorum stepped up his sales pitch for Plasma Technologies and the process the company has described as “disruptive and transformative,” according to the records.

In mid-August, the federal government awarded Plasma Technologies a $750,000 grant to demonstrate that it could deliver on its promises.

HHS would not comment when asked whether Santorum’s public backing of the president helped the company he has a financial stake in getting a government contract.

Santorum told the AP it would have been a

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Older males recovering from COVID-19 may have best plasma to treat it

A new study has found higher numbers of anti-SARS-CoV-2 antibodies in older males who required hospitalization for COVID-19.

Scientists have found that being hospitalized with COVID-19, as well as being male and of older age, increases the chances of a person having high plasma levels of antibodies that can protect against the disease.

This plasma, which is a component of blood, may help treat the disease in others.

The research, which features in the Journal of Clinical Investigation, is the first step toward confirming whether blood plasma therapy is effective in treating COVID-19.

As scientists continue to search for an effective vaccine for SARS-CoV-2, the virus that causes COVID-19, treatments that can reduce the risk of death are crucial for lowering the mortality rate associated with the disease.

However, to date, research has shown few treatments to be effective.

Furthermore, a major study by the World Health Organization (WHO) — currently available as a preprint — found that remdesivir, the most promising treatment for COVID-19, appears to make no significant difference to the mortality rate.

One possible treatment that may be effective is antibody therapy through convalescent plasma infusion.

Antibody therapies work by infusing a person who has an infection with the plasma of a person who has overcome that infection. The plasma of the person who has recovered may contain antibodies that their body created in response to the initial infection.

Research has suggested that this may be effective in treating people with COVID-19, and observational studies have, so far, produced promising results. However, further research is necessary to confirm these initial findings.

For this research to proceed, however, scientists need a greater knowledge of the makeup of the blood plasma that the process uses so that they can develop a standardized approach to the treatment.

To contribute to this goal, the scientists behind the present article conducted a study to determine what effect age, sex, and the severity of the disease had on the size and overall quality of a person’s antibody response to SARS-CoV-2.

This is important as the antibody response that COVID-19 induces can vary significantly. The scientists behind the present study suggest that this may be because antibodies are typically linked to disease severity, and COVID-19 symptoms can range from undetectable to life threatening.

Determining what factors lead to blood plasma containing antibodies of good quantity and quality may make it easier to standardize and optimize the treatment.

The study involved 126 adults who had recovered from a COVID-19 infection. The researchers took blood from the participants, as well as information regarding their age, sex, and whether they required hospitalization for the disease.

The scientists analyzed the plasma’s ability to neutralize the cells of SARS-CoV-2 in cell cultures. They also used commercially available tests to determine the level of antibodies.

They found that a strong antibody response was associated with hospitalization for

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Covid Plasma therapy controversy and the first Nobel prize in medicine!

The latest controversy in COVID 19 regarding the usefulness of plasma therapy after ICMR – WHO disowned it and the government of Delhi insisted on its use, has brought the issue back into focus.

It is a little known fact that the knowledge that antibodies present in the plasma of an infected patient can be used as a useful drug to combat and cure the disease, had brought the very first Nobel Prize in Physiology or Medicine in the year 1901.

This Nobel Prize went to Emil Von Behring who is regarded as the founder of Plasma Therapy.

Behring belonged to an era when modern scientific understanding of microbiology and immunology was nascent. He worked with all-time greats such as Louis Pasteur, Robert Koch, P. Ehrlich, Loeffler; the who’s who amongst the founding fathers of modern medical science in late nineteenth century. They together produced several research papers in the diverse field of Bacterial immunology. Behring specially worked towards curing the curse of Diphtheria, Tetanus and also controlling the menace of Tuberculosis in the later part of his life. These problems together were responsible for milllions of helpless deaths in those days.

Behring was born on 15th March 1854 in Hansdorf (West Prussia), now Poland, in a large family of 13 siblings. His father was a school teacher who had difficulty in supporting his family with meagre income. After studying medicine with full scholarship in military medical school Behring joined the armed forces so that he could start supporting his family. He spent most part of his active life in Germany and France where later on he would get the

chance to work at the famous ‘Pasteur Institute ‘and subsequently at Marburg where he became professor of infectious diseases.

In the year 1898 – 99, he demonstrated that Diphtheria culture, when separated from bacilli completely, still contained pure toxins and that these toxins were lethal. Such toxins, when injected into animals (initially guinea pigs and later on horses) produced copious antitoxins. When plasma containing such antitoxins was transfused into diseased animals, and later on in human beings, it controlled and cured the certain fatal disease.

This instantly brought Behring huge fame and recognition and consequently the very inaugural Nobel Prize was awarded to him in the year 1901 by Nobel foundation.

Later on, with F. Wernicke, he established that lasting immunity to diphtheria could be produced for prophylaxis by injecting the toxin-anti-toxin  mixture producing antibodies which could neutralise the lethal bacterial toxins and antigens, eventually leading to final banishment of diphtheria from the scourges of mankind.

I don’t think the last word on the usefulness of plasma therapy has been pronounced as yet. The fact that monoclonal antibodies based on the same basic principle, made of specific clones against COVID antigens recently produced by REGENERON and used for American President Trump’s successful treatment vindicates its basic premise!

The Author is Currently Professor of medicine at Manipal Tata Medical College and Formerly Professor and Head, Department of Medicine at Rajendra Institute

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A New, Large Study Finds Plasma Does Not Lower Risk of Dying from COVID-19


Credit – AFP via Getty Images

Researchers in India report that COVID-10 patients who received convalescent plasma from recovered patients did not see a lower risk of dying from the disease.

The study, published in BMJ, included 464 people with moderate COVID-19 disease, meaning they had oxygen saturation levels of 93% or less when breathing room air, the criterion that most doctors use to determine if they should hospitalize people who are infected with SARS-CoV-2, the virus that causes the illness. Study co-author Aparna Mukherjee, a scientist in epidemiology and communicable diseases at the Indian Council of Medical Research, notes that patients in her study would likely be considered severely ill in other countries, since definitions of illness vary considerably around the world. Once in the hospital, some patients in the study received two doses of convalescent plasma from those who had recovered from the disease and donated their immune cell-rich blood. These patients were compared to those treated with standard of care, who acted as a control group (but did not receive a placebo infusion). Both groups had similar mortality rates after 28 days.

“This study had a large sample size and it showed that when plasma is infused in patients who have moderate COVID-19 (similar to severe in other countries), it did not reduce mortality or progression to more critical COVID-19,” Aparna Mukherjee, a scientist in epidemiology and communicable diseases at the Indian Council of Medical Research and one of the co-authors of the study, said in an email response to questions.

The results add to the continued debate over how useful convalescent plasma might be as a treatment for COVID-19. Convalescent plasma is one of the oldest therapies that doctors have used in treating infectious diseases, based on the idea that people who are naturally infected and recover will have a ready supply of the proper immune cells needed to fight off the virus or bacteria in question. But because people’s immune systems vary widely, their volume of disease-fighting cells is also unpredictable, and may range from barely adequate levels to extremely rich sources of immune cells. That variability has led to conflicting results on the effectiveness of the therapy, including in this study, which used donated plasma from people who were sick for an average of six days with what the authors describe as mild disease.

Two other international studies also failed to find a benefit of convalescent plasma, but those were stopped early because too few eligible patients were enrolled. Other, smaller studies were more encouraging, so in the U.S. the Food and Drug Administration issued an emergency use authorization for the therapy in August that allows doctors to treat patients with plasma. Key public health leaders including Dr. Francis Collins, director of the National Institutes of Health, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, however, have noted that researchers are still studying convalescent plasma’s role in COVID-19. Those ongoing studies are comparing people who receive

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Don’t Give up on COVID-19 Plasma, Experts Say, After Study Finds No Benefit | Top News

LONDON (Reuters) – Researchers called on Friday for more research into using blood from recovered COVID-19 patients – or so-called convalescent plasma – as a potential treatment, after a small trial of hospitalised patients in India found it was of no benefit

The Indian results, published in the BMJ British Medical Journal, found that the plasma, which delivers antibodies from COVID-19 survivors to infected people, did not help hospitalised patients fight off the infection, and failed to reduce death rates or halt progression to severe disease.

The findings are a setback for a potential therapy that U.S. President Donald Trump touted in August as a “historic breakthrough”, and one experts say has been used in some 100,000 patients in the United States already, despite limited evidence on its efficacy.

Scientists not directly involved in the India study, which involved around 460 patients, said its results were disappointing but should not mean doctors give up hope altogether on convalescent plasma.

They said further and larger trials are needed, including in COVID-19 patients with milder disease and those newly infected.

“With just a few hundred patients, (the India trial) is still much too small to give clear results,” said Martin Landray, a professor of medicine and epidemiology at Britain’s Oxford University.

“One could well imagine that the treatment might work particularly well in those earlier in the course of the disease or who have not been able to mount a good antibody response to the virus of their own,” he said. “But such speculation needs to be tested – we can’t just rely on an educated guess.”

While the United States and India have authorised convalescent plasma for emergency use, other countries, including Britain, are collecting donated plasma so that the treatment could be widely rolled out if it is shown to be effective.

The Indian researchers enrolled 464 adults with COVID-19 who were admitted to hospitals across India between April and July. They were randomly split into two groups – with one receiving two transfusions of convalescent plasma alongside best standard care, and the other getting best standard care only.

After seven days, use of convalescent plasma seemed to improve some symptoms, such as shortness of breath and fatigue, and led to higher rates of so-called negative conversion – a sign that the virus is being neutralised by antibodies.

But this did not translate into a reduction in deaths or progression to severe disease by 28 days.

Ian Jones, a Reading University professor of virology, agreed with Landray that plasma may be more likely to work very soon after someone contracts COVID-19.

He urged these and other researchers to continue to conduct trials, and to do so in newly diagnosed patients.

“We still do not have enough treatments for the early stage of disease to prevent severe disease and until this becomes an option, avoiding being infected with the virus remains the key message,” he said.

(Reporting by Kate Kelland; Editing by Peter Graff and Frances Kerry)

Copyright 2020 Thomson Reuters

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Convalescent Plasma Of Limited Use For Covid-19: Study

Plasma taken from the blood of people who have recovered from Covid-19 and given to people sick with the disease does not reduce their chances of getting seriously ill or dying, new research has found.

The findings are from one of the first clinical trials to report the effects of convalescent plasma, which has been given emergency approval in countries including India and the United States.

As a potential treatment for patients with moderate Covid-19, particularly in places where laboratory capacity is limited, the study conducted across India and published in the medical journal BMJ Friday concluded that “convalescent plasma showed limited effectiveness”.

But the researchers said future studies could explore using only plasma with high levels of neutralising antibodies to see if this might be more effective.

With few useful treatments and no cure or vaccine, nations are scrambling to find ways to blunt the severity of the new coronavirus.

One idea has been to harvest recovered patients’ antibodies, which float in plasma — the liquid component of blood — and then inject this into the blood of someone fighting infection.

The technique was first tried against diphtheria in 1892 and was shown to help speed recovery from Ebola and SARS, which is caused by the same family of pathogens as the novel coronavirus.

Observational studies recently carried out suggested convalescent plasma could be beneficial.

But in a randomised clinical trial at dozens of public and private hospitals across India, researchers found that it failed to reduce mortality or stop progression to severe Covid-19 in moderately ill patients.

Convalescent plasma has been given emergency approval for use in countries including India and the United States Convalescent plasma has been given emergency approval for use in countries including India and the United States Photo: AFP / TAUSEEF MUSTAFA

The study, funded by the Indian Council of Medical Research, enrolled 464 adult patients, with an average age of 52, between April and July and split them randomly into two groups.

A control group of 229 was given the normal best standard of hospital care, while 235 people received two transfusions of convalescent plasma and were then given the best standard of hospital care.

After 28 days, 44 (19 percent) of the participants in the plasma group and 41 (18 percent) in the control group progressed to severe disease or died from any cause.

When they restricted the comparison to patients who received plasma with detectable levels of antibodies, the results were the same, the authors said.

They did however find that the use of convalescent plasma seemed to improve resolution of shortness of breath and fatigue and led to higher conversion to a negative result for the virus — a sign of it being neutralised by antibodies — after 7 days.

The trial “was a rigorous randomised controlled study on a topic of enormous global importance” said public health scientist Elizabeth Pathak in a separate commentary also published in the BMJ.

But the results were greeted with caution by a spokesman from Britain’s National Health Service, which is also in the process of carrying out large, randomised control

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Convalescent plasma did not reduce Covid-19 deaths or keep patients from severe illness in new study

The study, conducted in India and published in the medical journal the BMJ on Thursday, suggests that “as a potential treatment for patients with moderate Covid-19, convalescent plasma showed limited effectiveness.”

Convalescent plasma is the antibody-rich serum taken from the blood of people who recovered from Covid-19. The idea is that the plasma can help the immune response of patients still fighting the disease.

In August, the US Food and Drug Administration authorized the emergency use of convalescent plasma as a treatment option for hospitalized Covid-19 patients. However, data were still being collected in randomized controlled trials — the gold standard — to study the safety and effectiveness of the treatment. Last month, a National Institutes of Health panel said there’s no evidence backing the use of convalescent plasma to treat coronavirus patients and that doctors should not treat it as a standard of care until more study has been done.

Randomized controlled trials of convalescent plasma to treat Covid-19 patients are still underway in the United States.

The new study, called the PLACID trial, included data on 464 adults with moderate Covid-19 in 39 hospitals across India. Among them, 235 patients were randomly selected to receive convalescent plasma along with standard care for treatment and 229 patients received only standard care.

The new study showed that a higher proportion of patients who received convalescent plasma saw improvements in their symptoms of fatigue and shortness of breath compared with those given standard care, but there was no difference between patients when it came to resolving fever and cough.

The proportion of patients who needed invasive ventilation did not differ among the two groups, and overall, the researchers found that 34 patients who received convalescent plasma, or 15%, had died — compared with 31 who were given standard care, or 14%.

Dozens of hospitals poised to defy FDA's directive on Covid plasma

The study had some limitations, including that it was an “open label design” so the physicians treating the patients knew who was given convalescent plasma and who wasn’t. Additionally, more research is needed to determine whether similar findings would emerge among a larger group of patients in other parts of the world.

Simon Clarke, an associate professor in cellular microbiology at the University of Reading in the United Kingdom, called the new study “a blow” to the use of convalescent plasma as a Covid-19 treatment.

“While this is a blow to the use of plasma therapy for Covid-19, it should not be abandoned, there may be ways to refine it as a treatment and deliver solid, demonstrable benefits,” Clarke said in a written statement distributed by the UK-based Science Media Centre.
Researchers hope this old-fashioned treatment will work for coronavirus

“Use of someone’s blood plasma that contains antibodies against a virus or bacteria to treat an infection in someone else, is not a new technology and although usually safe, is not entirely without risk,” said Clarke, who was not involved in the new study.

“The PLACID trial was able to show a small effect on the rate at which patients were able rid themselves of the virus, but this

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Convalescent plasma questioned as coronavirus treatment in India: report

Government officials in India are contemplating dropping plasma from coronavirus therapies after a study found it ineffective, per multiple reports.

Dr. Balram Bhargava, chief of the Indian Council of Medical Research (ICMR), said the forthcoming study in the British Medical Journal revealed plasma didn’t lower deaths or prevent progression to severe disease among 464 patients, per Times of India.

Plasma from recovered COVID-19 cases is transfused to critically ill COVID-19 patients, with the hope that the antibodies will help the patient fight or neutralize the disease. 

“We have discussed this in the national task force and are discussing further now with the joint monitoring group that this [plasma therapy] may be deleted from the national guidelines,” Bhargava said, per the outlet. “That discussion is ongoing and more or less we are reaching towards that.” 

Plasma from recovered COVID-19 cases is transfused to critically ill COVID-19 patients, with the hope that the antibodies will help the patient fight or neutralize the disease. (iStock)

Plasma from recovered COVID-19 cases is transfused to critically ill COVID-19 patients, with the hope that the antibodies will help the patient fight or neutralize the disease. (iStock)


However, others still have hope.

Satyendar Jain, Delhi health minister, on Wednesday reportedly discussed 2,000 patients who improved from the therapy, touting plasma for saving his own life, one outlet wrote.

“Even America has acknowledged its benefit,” Jain said, per The Economic Times. “Delhi in a way is a pioneer in it and plasma therapy benefits have been seen. You should go and ask family members of those patients who were administered the plasma therapy,” he said.

President Trump announced FDA emergency approval for plasma in August, though top experts, namely Dr. Anthony Fauci and Dr. Francis Collins, voiced concerns over inadequate evidence shortly before the approval which temporarily paused the process. 


“This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection,” Trump had said, adding that the authorization would “expand access to this treatment.”

On its webpage, the FDA notes a “statistically significant 37% reduction in mortality in those treated with high titer convalescent plasma,” or in simpler terms, plasma with higher levels of antibodies.

A study by the Mayo Clinic of over 35,000 patients found that plasma with high antibody levels “significantly reduced mortality” in hospitalized COVID-19 patients, 52% of whom were in intensive care.

When the treatment was administered early (within three days), there were fewer deaths.

Fox News Bradford Betz contributed to this article.


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BioLife Plasma Services Announces Opening of First Plasma Collection Center in Nebraska

New center in Omaha opens to support an urgent patient need for human plasma

BioLife Plasma Services, part of the global biopharmaceutical company Takeda Pharmaceutical Company Limited, today announced the opening of a new plasma collection center in Omaha to collect standard plasma from healthy donors.

“Now, more than ever, donors in the Omaha area have a unique opportunity to make a difference in the community through plasma donation, and we are deeply committed to making treatment options available for patients who rely on plasma-derived medications,” said Jacy Cizek, manager of the BioLife Plasma Services Omaha center. “Plasma is a lifeline for thousands of people with rare, chronic and complex diseases, and we are excited to open the first BioLife plasma collection center in Nebraska.”

Through a simple, low-risk process called plasmapheresis, plasma is separated from the blood and the blood elements are returned back into the donor’s body. Screened plasma collected from healthy individuals is processed into a wide variety of therapeutics for people around the world with rare, life-threatening diseases, such as immunodeficiency disorders, hemophilia and hereditary angioedema.

Due to the COVID-19 pandemic, BioLife Plasma Services has implemented additional screening and safety measures in line with public health guidance to help guarantee the safety and health of donors and employees, as well as the safety of the collected plasma. All donors will need to wear a mask or other cloth face covering inside a BioLife Plasma center.

Prospective donors can make online appointments to visit the Omaha center (275 N. 78th St., Omaha, NE 68114), which opens on Saturday, October 24. They must pass a physical examination at their first visit and are screened at each visit to ensure they meet eligibility criteria. All donors are compensated for their time and commitment.

The Omaha center is approximately 11,330 square feet, and the state-of-the-art facility provides access to free Wi-Fi and a clean, professional, smoke-free environment. The new center is the first BioLife center to open in Nebraska and expects to bring more than 50 new jobs to the community.

To learn more about BioLife Plasma Services, the donation process, and to schedule an appointment, please visit the BioLife website.

About Plasma

Plasma is the clear, straw-colored liquid portion of blood that can be easily replaced by the body. Plasma makes up more than half of whole blood and consists primarily of water and proteins. During plasma donation, a donor’s blood is collected into an automated device that separates the plasma from the other whole blood components, including red and white blood cells and platelets. While the plasma is collected, the other blood components are returned to the donor. Each donation procedure uses sterile and disposable collection materials. The body quickly replaces the plasma removed during the donation process, which allows healthy individuals to donate as often as twice in a seven-day period, with at least one day between donations.

About BioLife Plasma Services

BioLife Plasma Services is an industry leader in the collection of high-quality

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Prehospital Plasma Boosts Survival in Traumatic Brain Injury

Prehospital plasma, administered soon after injury, appears to improve survival for patients with traumatic brain injury (TBI), results of a new analysis suggest.

Administration of prehospital plasma demonstrated a strong survival benefit and was associated with a 45% lower risk for mortality in TBI patients, Danielle S. Gruen, PhD, and colleagues write in their report, published online October 15 in JAMA Network Open.

The finding is from a post hoc secondary analysis of a prespecified subgroup from the Prehospital Air Medical Plasma (PAMPer) randomized clinical trial, published in 2018 in The New England Journal of Medicine.

PAMPer studied the safety and efficacy of prehospital administration of thawed plasma in injured patients at risk for hemorrhagic shock. It included 501 patients; 230 received prehospital plasma, and 271 received standard-care resuscitation that did not include prehospital plasma administration.

Results showed that mortality at 30 days, the trial’s primary endpoint, was significantly lower in the plasma group than in the standard-care group (23.2% vs 33.0%; P = .03).

The current analysis explored the association between prehospital plasma resuscitation and survival in a subgroup of 166 patients with TBI. Of these, 74 patients received prehospital plasma, and 92 received standard care.

Dr Jason Sperry

“If you give prehospital plasma to injured patients, there is a survival benefit, as PAMPer showed, and the current study demonstrates that the signal is strongest in patients who have traumatic brain injury,” senior author Jason L. Sperry, MD, MPH, professor of surgery and critical care, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, told Medscape Medical News.

“We think that giving plasma as soon as possible improves survival via several mechanisms,” he said. “These include volume expansion to restore perfusion, an alteration in the inflammatory response, a reduction in endothelial injury, and the prevention or mitigation of coagulopathy.”

The median age of the patients with TBI was 43 years (range, 25 – 60 years). Brain injury was shown on CT imaging. Most patients with TBI were men (n = 125, 75.3%), and all had blunt trauma injuries. The median Injury Severity Score was 29 (interquartile range [IQR], 22 – 38).

Patients with TBI were more severely injured than those without TBI, and the incidence of prehospital intubation was higher for those patients. In addition, they were more likely to receive in-hospital vasopressors, the length of stay in the intensive care unit was longer, they spent more days on mechanical ventilation, and 24-hour mortality rates (P = .001) and 30-day mortality rates (P = < .001) were higher.

Except for the plasma intervention, there were no significant differences in fluid administration during transport to the hospital. However, in-hospital transfusion requirements differed between the two groups. Patients with TBI who were treated with prehospital plasma received less crystalloid fluid, vasopressors, and packed red blood cells in the first 24 hours.

In addition, for patients with TBI who received prehospital plasma, international normalized ratios were lower (median, 1.20 [IQR, 1.10 – 1.40] vs 1.40 [IQR 1.20 – 1.80]).

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