Effect of Cold Stored Platelets to Slow or Stop Severe Internal Bleeding in Trauma Patients

About This Study

What is Trauma?

Trauma is a physical injury usually caused by violence or road traffic accidents.  Trauma is the leading cause of death in people younger than 45 years. Trauma patients may have extensive internal bleeding. People who suffer severe trauma usually need emergency care to stop bleeding.

What is Damage Control Resuscitation?

Damage Control Resuscitation (DCR) is often initiated when trauma patients arrive at level 1 trauma centers such as LAC+USC Medical Center with severe bleeding that requires a large amount of blood products to be infused in order to save their lives. DCR is the early transfusion of blood components (packed red blood cells, plasma and platelets) to prevent the body from losing its ability to form blood clots after severe injury.

What is the CriSP Study?

Platelet transfusions are a vital component of DCR and are essential to blood clot formation and early stopping of severe bleeding. In usual care, platelets are stored in room temperature because they survive longer once infused into the body compared to cold-stored platelets. However, there are studies that suggest that cold-stored platelets can still be effective in early stopping of severe bleeding. This study is being done to see if giving Cold-Stored Platelets early in the course of treatment is feasible and if it would help improve outcomes in injured patients that lose a lot of blood.

Why do this study?

There is some information that suggests that severely injured people who are given platelets soon after arriving at the hospital may have improved survival. By providing Cold Stored Platelets in an urgent release fashion following injury, a potentially superior blood clotting agent is given early, closer to the time of injury. The knowledge gained from this study will likely inform the design of future large randomized DCR clinical trials.

Who will be included?

• People who are 15 to 90 years old, who did not opt out of the study, and
• Traumatically injured and need DCR to save their lives

What are the study procedures?

People who meet the entry criteria will be randomly enrolled, like flipping a coin, into one of the two study groups:

• Damage Control Resuscitation only
• Damage Control Resuscitation plus one bag of Cold Stored Platelets

Cold Stored Platelets will be infused as soon as possible (Emergency Room or Operating Room).

Everyone will be given the standard medical care for traumatic injury regardless if they opt of the study or not. 

What is Exception from Informed Consent (EFIC)?

EFIC is a FDA rule that allows research studies in certain emergency situations to be conducted without consent.

EFIC can only be used when:

• The person’s life is at risk, AND, the treatments we have don’t work, AND, the study might help the person, AND,
• it is not possible to get permission from the person because of his or her medical condition NOR from the person’s guardian because there is a very short amount of time required to treat the medical problem.

People who have had severe internal bleeding are usually in shock due to the blood loss. The heavy loss of blood usually makes people feel confused and they are not in a state to give their consent to take part in a research study. In the majority of trauma cases, the injured person does not have any family nearby to give permission to participate on behalf of the injured person.

Cold Stored Platelets must be used as soon as possible to help slow or stop severe internal bleeding. The study doctors and study staff will make attempts to reach family before enrollment. If patients are enrolled into the study before consent was obtained, the study doctors and study staff will talk with the patient and/or family as soon as possible after the procedure to obtain consent for continued participation in the research. 

How many patients will be included in this clinical study? 

Nationally, the study plans to include up to 200 trauma patients at 5 hospitals around the country. At LAC+USC, we plan to include about 60 people in this clinical study.

If I do not wish to be included in this clinical study, how can I make my wish known?

If you do not wish to participate in this clinical study, please contact us by clicking on the survey link provided at the top and bottom of this site.  Take the survey, and at the bottom, provide your information. We will be happy to provide you with an ‘opt-out’ bracelet that you should wear for the duration of the study. You can also update and carry your Advance Medical Directive.  You can also let your family know your wishes. If you are in the study and decide you no longer want to participate, you can withdraw from the study by notifying the study team in person, in writing or by calling.

The Benefits

We are unsure if there are any benefits to receiving early Cold Stored Platelet. There is some information that suggests that severely injured people who are given platelets soon after arriving at the hospital may have improved survival. The risk of infection from bacterial contamination may be lower with cold stored platelets than with room temperature platelets.