The TROOP Trial is being conducted so that doctors can know whether whole blood or blood components work better in trauma patients who are severely injured and bleeding.

Whole blood is blood that has not been separated. Blood components are made from whole blood that has been separated. The separated components are plasma, red blood cells, and platelets. While some hospitals use whole blood, it is more common for patients to receive blood components.

No. The blood or blood components used in this study are the same products that hospitals normally keep in their blood banks for patients who need blood transfusions.

People who meet the following criteria will be included:

1. Adult trauma patient (estimated age > 15 or weight > 50 kg, if age unknown)
2. Patient was taken to the trauma center directly from the scene of their injury
3. Patients who have already received up to two units of blood before arriving at the hospital, or after arriving at the hospital
4. Patients with massive bleeding and are expected to receive a large amount of blood or blood products

People who meet any of the following will be excluded:

1. Patients who have received more than two units of blood or blood products
2. Patients transferred from another hospital
3. Children under the age of 15
4. Known prisoners
5. Patients who are not expected to survive their injuries
6. Patients who need surgery to open their chest, or have received more than 5 minutes of CPR
7. Patients with known “do not resuscitate” orders
8. Patients who refuse the administration of blood products for religious or other reasons
9. Individuals with a research “opt out” bracelet
10. Greater than 20% total body surface area (TBSA) burns
11. Suspected inhalation injury
12. Patients who are obviously pregnant on clinical examination

The study will take place in the UAB Emergency Department and at 11 other sites across the US.

The standard treatment of injured patients who are bleeding involves the transfusion of different types of blood products, as well as the use of medications to help the blood clot better (and surgery, to stop the bleeding). Even with these treatments 10-30% of patients suffering from a serious traumatic injury die. Everyone who participates in this trial will receive standard care.

The blood or blood products will be given as an intravenous (into a vein) infusion, which will begin within minutes of arriving in the emergency department. The treatment will be given in addition to all usual care. No care will be withheld because of the research trial.

There are no other research treatments once the infusion has been completed. We will record whether patients survive, and carefully monitor them for any complications. There are no additional hospital or clinic visits for the research study.

No. In order for us to be able to determine whether blood or blood products are better for trauma patients, half will receive blood and half will receive blood products. When an injured patient is brought to our emergency department, and deemed to meet the criteria for participation in the TROOP trial, doctors will open a special pack. The pack will contain either blood or blood products. 

The information collected in this study will be kept confidential to the extent allowed by law. Organizations overseeing the research, such as the Institutional Review Board or the FDA may inspect records of your hospitalization.

We are planning to enroll 1100 patients total.

In early 2023.

The study treatment is limited to the time of arrival in the hospital. After this, we will only record information from the medical record until the patient is released from the hospital, or for a maximum of 30 days (whichever is earlier).

We estimate that it will take a little more than 3 years to enroll the number of patients needed to complete the study.

Patients in this study will have suffered a serious and potentially life-threatening injury, causing significant blood loss, and requiring immediate life-saving interventions. These types of injuries occur unexpectedly, and it is not possible for people to sign up to take part ahead of time. Most patients will be unconscious (unable to speak or hear) and too sick to consent to immediate treatment, or participation in the study. Doctors will therefore enroll patients into the study without their consent.

Research is normally only conducted with the express permission of the patient. However, it is often not possible to obtain patients’ consent to study treatments that are administered in life-threatening emergencies – but such research still has to be done. The TROOP trial will be therefore conducted under federal regulations that allow an exception from informed consent (EFIC).

In 1996, the Food and Drug Administration (FDA) developed specific regulations to permit emergency research without consent, in special circumstances, and with additional safeguards. These regulations recognize that there are situations in which patients or family members cannot give informed consent – but that there is also a need to advance emergency care, through research. Read more [links to CIS page on EFIC]
If a family member or other legally authorized representative is present when the patient arrives in hospital, will they be asked for permission?

Yes – if there is time. In order to give permission to participate in a study, it is important that the person giving permission understands what is being said to them, and can make a well-informed decision. Family members are usually very upset during a medical emergency and are not able to concentrate or comprehend what is being said during the emergency. A serious injury is an extreme emergency during which the patient could potentially die if treatment is not begun immediately. Patients suffering significant blood loss may be unconscious or too sick to discuss their treatment, and any time taken to discuss their treatment with family deprives the patient of immediately starting life-saving measures.

Yes, we will inform patients, and their relatives, as soon as possible. Most of the time, the blood transfusions will have been given by the time we are able to reach relatives, or patients themselves are able to take in such information. If a patient, or legally authorized representative, decides that they do not wish to continue to be part of the study, then no further data will be collected.

Whole blood and blood products are approved by the Food and Drug Administration (FDA) for use in patients with severe bleeding. Patients who are in this study do not experience higher risks than patients who are not included. The risks of receiving blood and blood products are the same. These risks are rare, but include the following:

Allergic reaction:  An allergic reaction results from an interaction of an allergen in the transfused blood with preformed antibodies in the person receiving the blood transfusion. In some instances, infusion of antibodies from the donor may be involved. The reaction may present only with irritation of the skin or mucous membranes but can also involve serious symptoms such as difficulty breathing.

Acute hemolytic transfusion reaction (AHTR):  An acute hemolytic transfusion reaction is the rapid destruction of red blood cells that occurs during, immediately after, or within 24 hours of a transfusion when a patient is given an incompatible blood type. The recipient’s body immediately begins to destroy the donated red blood cells resulting in fever, pain, and sometimes severe complications such as kidney failure.

Delayed hemolytic transfusion reaction (DHTR):  A delayed hemolytic transfusion reaction occurs when the recipient develops antibodies to red blood cell antigens between 24 hours and 28 days after a transfusion. Symptoms are usually milder than in acute hemolytic transfusion reactions and may even be absent. DHTR is diagnosed with laboratory testing.

Delayed serologic transfusion reaction (DSTR):  A delayed serologic transfusion reaction occurs when a recipient develops new antibodies against red blood cells between 24 hours and 28 days after a transfusion without clinical symptoms or laboratory evidence of hemolysis. Clinical symptoms are rarely associated with DSTR.

Febrile non-hemolytic transfusion reaction (FNHTR):  Febrile non-hemolytic transfusion reactions are the most common reaction reported after a transfusion. FNHTR is characterized by fever or chills in the absence of hemolysis (breakdown of red blood cells) occurring in the patient during or up to 4 hours after a transfusion. These reactions are generally mild and respond quickly to treatment. Fever can be a symptom of a more severe reaction with more serious causes, and should be fully investigated.

Hypotensive transfusion reaction:  A hypotensive transfusion reaction is a drop in systolic blood pressure occurring soon after a transfusion begins that responds quickly to cessation of the transfusion and supportive treatment. Hypotension also can be a symptom of a more severe reaction and should be fully investigated.

Post-transfusion purpura (PTP):  Post-transfusion purpura is a rare but potentially fatal condition that occurs when a transfusion recipient develops antibodies against platelets, resulting in rapid destruction of both transfused and the patient’s own platelets and a severe decline in the platelet count. PTP usually occurs 5-12 days after a transfusion and is more common in women than in men.

Transfusion-associated circulatory overload (TACO): overload occurs when the volume of blood or blood components are transfused cannot be effectively processed by the recipient. TACO can occur due to an excessively high infusion rate or volume or due to an underlying heart or kidney condition. Symptoms may include difficulty breathing, cough, and fluid in the lungs.

Transfusion-related acute lung injury (TRALI):  Transfusion-related acute lung injury is a serious but rare reaction that occurs when fluid builds up in the lungs, but is not related to excessive volume of blood or blood products transfused. Symptoms include acute respiratory distress with no other explanation for lung injury such as pneumonia or trauma occurring within 6 hours of transfusion. The mechanism of TRALI is not well understood, but is thought to be associated with the presence of antibodies in donor blood

Transfusion-associated dyspnea (TAD):  Transfusion associated dyspnea is the onset of respiratory distress within 24 hours of transfusion that cannot be defined as TACO, TRALI, or an allergic reaction.

Transfusion-associated graft vs. host disease (TAGVHD):  Transfusion-associated graft vs. host disease is a rare complication of transfusion that occurs when donor T-lymphocytes (the “graft”) introduced by the blood transfusion rapidly increase in number in the recipient (the “host”) and then attack the recipient’s own cells. Symptoms include fever, a characteristic rash, enlargement of the liver, and diarrhea that occur between 2 days and 6 weeks post transfusion. Though very rare, this inflammatory response is difficult to treat and often results in death.

Transfusion-transmitted infection (TTI):  A transfusion-transmitted infection occurs when a bacterium, parasite, virus, or other potential pathogen is transmitted in donated blood to the transfusion recipient.

Risk to women of childbearing age: Alloimmunization: This condition occurs when a person’s immune system creates antibodies to another blood type. It can occur when someone receives a blood transfusion that is a different blood type from their own. If you have a negative blood type, receiving a transfusion may result in alloimmunization, which could cause destruction of red blood cells of the fetus in a future pregnancy. The risk of developing this condition is approximately 17%, while the risk of serious fetal problems is thought to be low – less than 1%

No. Neither the University of Alabama at Birmingham, nor the study sponsor (NHLBI) have provided for any payment if you are harmed as a result of taking part in this study. If such harm occurs, treatment will be provided; however this treatment will not be provided free of charge.

Yes. We will provide an “Opt Out of Trauma Research” wristband for those people who do not want to be enrolled in the study.

This study will be performed at the following sites:

• Baltimore, MD: The University of
• Maryland Medical Center
• Birmingham, AL: The University of Alabama at Birmingham (lead site)
• Cincinnati, OH: University of
• Cincinnati Medical Center
• Houston, TX: University of Texas Health Science Center at Houston
• Los Angeles, CA: LAC + USC Medical Center
• Milwaukee, WI: Froedtert Hospital
• New Orleans, LA: Tulane University Medical Center New Orleans LCMC Health
• Philadelphia, PA: Penn Presbyterian Medical Center
• Portland, OR: Oregon Health & Science University
• Seattle, WA: Harborview Medical Center
• St. Louis, MO: Washington University School of Medicine
• Winston Salem, NC: Atrium Health Wake Forest Baptist

Research staff can be contacted at (205) 934-5890 or via email at cis@uabmc.edu.