(PROPPR)

R ADAMS COWLEY SHOCK TRAUMA CENTERUNIVERSITY OF MARYLAND MEDICAL CENTERCommunity Consultation

PRINCIPAL INVESTIGATOR: THOMAS SCALEA, MD

Sponsored by National Heart Lung and Blood Institute (NHLBI), National Institutes for Health (NIH)

Pragmatic, Randomized Optimal Platelet and Plasma

Ratios

What is Trauma?

Refers to a “a body wound or shock produced by sudden physical INJURY, as from violence or accidents.

Leading cause of death in people under the age of 45 years old.

People who have suffered trauma may require specialized care, including BLOOD TRANSFUSIONS and SURGERY.

Background

Nearly 50% of trauma deaths occur before the patient reaches the hospital and few of these deaths are preventable.

For those that reach the hospital, about 40% experience bleeding complications and require a MT (massive transfusion of at least 10 units of blood)

Bleeding complications are the leading cause of early death in trauma patients.

Background

Current military transfusion guidelines for massively transfused casualties are based on the U.S. Army Surgeons General recommendation of a 1:1:1 ratio.

Studies in both the public and military populations have shown that seriously injured patients who received a massive transfusion (MT) with higher plasma ratios had lower mortality than those who received more traditional ratios of plasma.

Question remains: What is the best ratio group to use for trauma patients who require a large amount of blood?

What is the PROPPR study?

This study involves research.

Multi-center study including at least 12 North American Level 1 trauma center sites.

Purpose: Determine what the best ratio of products is to provide the best outcomes for the patients.

Plan: Enroll patients who are PREDICTED to receive significant amounts of blood products into a protocol using 1:1:1 ratios of plasma to platelets to red blood cells (RBCs), compared to 1:1:2

The knowledge gained will likely impact the way in which massively bleeding patients are transfused and lower the amount of otherwise preventable deaths resulting from hemorrhagic shock

What Are Red Blood Cells, Platelets, Plasma

Red Blood Cells are cells that carry oxygen

Platelets are the smallest structures in the blood and are important for blood clotting and plugging damaged blood vessels.

Plasma is the liquid portion of the blood; represents approximately 50% of the total volume of blood and contains coagulation proteins

Patient Selection

Inclusion

Severely injured

Estimated age 15 years or older or greater than/equal to weight of 50 kg if age unknown

Received directly from scene of injury

Received at least one unit of blood product products within the first two hours of injury

Predicted to receive a massive transfusion by scoring system or the attending trauma surgeon’s judgment

Exclusion

Received care from outside hospital Non-survivable injuries Prisoners directly admitted from jail Required emergency thoracotomy Children less than 15 years or less

than 50 kg body weight if age unknown

Obvious pregnancy Severely burned Had at least 5 minutes of CPR with

chest compressions before admission

Known “Do Not Resuscitate” orders prior to randomization

Enrolled in a concurrent ongoing interventional, randomized clinical trial

Patients who wear “opt-out” bracelet

Religious objections to blood transfusions

How are patients selected for this study?

The trauma physician on call in the emergency department will use information obtained when a patient first arrives to predict if he/she will require a significant amount of blood products. The information includes blood pressure, pulse, type of injury, and an ultrasound test to see if there is bleeding in the abdomen (FAST exam).

For patients who are eligible for this study, the blood bank will be notified to randomize (a process like flipping a coin) the patient to receive one of two ratio groups (either 1:1:1 or 1:1:2).

The study blood products will be given ONLY in the initial 24 hours.

What about other treatments and care?

People enrolled in this study will continue to receive all other treatments and care they would have received anyway. If you are not in the study, the only difference would be that the combination of blood products given would be decided by the physicians and not by the study randomization.

Group 11:1 RatioGroup 11:1 Ratio

Group 21:2 RatioGroup 21:2 Ratio

Every other cooler

How will the PROPPR transfusion be given?

Every cooler

Is the blood safe?

All blood products we use will be processed through the Blood Bank and Transfusion Service in the Laboratories of Pathology at the University of Maryland Medical Center

All blood products are approved by the U.S. Food and Drug Administration (FDA) and the American Association of Blood Banks (AABB), and/or Health Canada

All blood products are typed and crossed

All blood products will be tested for infectious diseases

All hospitals have established policies and procedures to safely transfuse blood products

What will be studied?

We will collect blood samples upon arrival and up to 72 hrs Time points: at 0, 2, 4, 6, 12, 24, 48, and 72 hours (or

discharge from hospital – whichever occurs first) Up to a total of 23 cc of blood will be collected at each time

point for research purposes

Daily medical record will be reviewed

The 0 hour sample will be collected on all potential patients and stored for future tests which WILL NOT include genetic testing with the patient’s approval.

The patient will be contacted by the study team near the 30th day following the emergency department admission to find out how they are doing on day 30

Any Risks?

You would have these risks whether or not you were in the study but it is unknown at this time whether these risks (for example, lung injury) are more severe or last longer when one unit of red blood cells is administered for every unit of platelets and plasma compared with two units of red blood cells administered for every unit of platelets and plasma

Risks include: chance of transmission of an infectious disease, low blood pressure, allergic reaction, shortness of breath, fever, blood clotting problems

What is the informed consent process?

The consent process is when we ask a person’s permission and invite him/her to be in a study, explaining the risks and benefits, as well as answering any questions

Patients will be unable to consent

People will be entered into the study without providing informed consent

Every attempt will be made to obtain consent from the legal representative and/or family member to join or continue with the study or to refuse to allow the patient to join or continue in the study

Enrolled patients will be informed of study when able and will be allowed

INFORMATION YOU SHOULD KNOW

Patients and/or their family members/legal representatives can decide at any time to withdraw from a study

Patients will receive the same care whether they are not they are in the study

There is no extra cost for being in the study; the patient will not receive compensation for being in the study

If an injury occurs which is related to the study, the patient will not receive compensation for the injury and medical care will be available just as it is to the general community

INFORMATION YOU SHOULD KNOW

Every effort will be made to ensure patient privacy All data reviewed for the purposes of this study will be de-

identified- personal identification such as name, medical record number will be removed

The FDA may inspect the records at any time

Members of the community may “opt-out” if they do not wish to be in the study. A colored, plastic bracelet with the word “PROPPR Ø” on it will be available for those who DO NOT want to be considered for this study. If a patient arrives to the ED with this bracelet on, they will not be screened or enrolled in this study

Questions?

For questions pertaining to this study or if you would like to “opt out” of the study

Thomas Scalea, MD410-328-8976

For questions pertaining to informed consent: University of Maryland School of Medicine

Human Research Protections Office410-706-5037

THANK YOU