Transcript Propsective, Randomized Optimal Platelet and Plasma Ratios

Pragmatic, Randomized Optimal
Platelet and Plasma Ratios
(PROPPR)
R ADAMS COWLEY SHOCK TRAUMA CENTER
UNIVERSITY OF MARYLAND MEDICAL CENTER
Community Consultation
PRINCIPAL INVESTIGATOR: THOMAS SCALEA, MD
Sponsored by National Heart Lung and Blood
Institute (NHLBI), National Institutes for Health
(NIH)
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
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Severely injured
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Estimated age 15 years or older or
greater than/equal to weight of 50 kg if
age unknown
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Received directly from scene of injury
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Received at least one unit of blood
product products within the first two
hours of injury
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Predicted to receive a massive
transfusion by scoring system or the
attending trauma surgeon’s judgment
Exclusion
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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.
How will the PROPPR transfusion be given?
Group 1
1:1 Ratio
Group 2
1:2 Ratio
Every cooler
Every other 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
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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, MD
410-328-8976
 For questions pertaining to informed consent:
University of Maryland School of Medicine
Human Research Protections Office
410-706-5037
THANK YOU