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TraumaPhase 3PROPPRNCT01545232

Pragmatic, Randomized Optimal Platelet and Plasma Ratios

A Phase 3 study testing 1:1:1 Blood Transfusion Ratio and 1:1:2 Blood Transfusion Ratio in people with Trauma, run by The University of Texas Health Science Center, Houston at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted to receive massive transfusion ([MT] (defined as receiving 10 units or more red blood cells (RBCs) within the first 24 hours). Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Trauma
What is being tested?
1:1:1 Blood Transfusion Ratio and 1:1:2 Blood Transfusion Ratio
Could I receive a placebo?
No, everyone receives an active treatment
How many people
680 participants
Where
12 sitesin 2 countries
Study dates
Aug 2012to Dec 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects who require the highest trauma team activation at each participating center,
  • Estimated age of 15 years or older or greater than/equal to weight of 50 kg if age unknown,
  • Received directly from the injury scene,
  • Initiated transfusion of at least one unit of blood component within the first hour of arrival or during prehospital transport, and
  • Predicted to receive a MT by exceeding the threshold score of either the Assessment of Blood Consumption (ABC) score or the attending trauma physician's judgment criteria

Who cannot join

  • Received care (as defined as receiving a life saving intervention) from an outside hospital or healthcare facility (Procedures and care given at an outside health facility cannot be documented or controlled resulting in a high variability of standards of care and clinical outcomes.)
  • Moribund patient with devastating injuries and expected to die within one hour of Emergency Department (ED) admission
  • Prisoners, defined as those who have been directly admitted from a correctional facility
  • Patients requiring an emergency thoracotomy
  • Children under the age of 15 years or under 50 kg body weight if age unknown
  • Known pregnancy in the ED
Show all 12Show fewer
  • Greater than 20% total body surface area (TBSA) burns
  • Suspected inhalation injury
  • Received greater than five consecutive minutes of cardiopulmonary resuscitation (CPR with chest compressions) in the pre-arrival or ED setting
  • Known Do Not Resuscitate (DNR) prior to randomization
  • Enrolled in a concurrent, ongoing interventional, randomized clinical trial
  • Patients who have activated the "opt-out" process or patients/legally authorized representatives that refuse blood products on arrival to ED.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States11 sites

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • University of Alabama

    Birmingham, Alabama, 35233

  • University of Cincinnati

    Cincinnati, Ohio, 45221

  • University of Texas Health Science Center- Memorial Hermann Hospital

    Houston, Texas, 77030

  • University of Southern California, Los Angeles

    Los Angeles, California, 90033

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38103

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • University of California, San Francisco

    San Francisco, California, 94143

  • University of Washington- Harborview Medical Center

    Seattle, Washington, 98104

  • University of Arizona

    Tucson, Arizona, 85721

Other trials in United States

Canada1 site

  • Sunnybrook Health Science Center

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted to receive massive transfusion ([MT] (defined as receiving 10 units or more red blood cells (RBCs) within the first 24 hours). The goal of PROPPR is to improve the basis on which clinicians make decisions about transfusion protocols for massively bleeding patients.

PROPPR is a Resuscitation Outcomes Consortium (ROC) Protocol. ROC is funded by the National Heart, Lung, and Blood Institute (NHLBI), the United States' Department of Defense (DoD) and the Defence Research and Development Canada. PROPPR will be conducted as a Phase III trial at Level I Adult Trauma Centers in North America.

Read the detailed description

Background: Multiple observational studies have reported that blood product component ratios (i.e., plasma:platelets:RBCs) that approach the 1:1:1 ratio, found in fresh whole blood, are associated with significant decreases in truncal hemorrhagic death and in overall 24-hour and 30-day mortality among injured patients. The rationale for the 1:1:1 ratio is that the closer a transfusion regimen approximates whole blood, the faster hemostasis will be achieved with minimum risk of coagulopathy. The current DoD guideline specifies the use of 1:1:1, and this practice is followed on almost all combat casualties. In other observational studies, leading centers have reported good outcomes across a range of different blood product ratios. For example, a 1:2 plasma:RBC ratio is used with little guidance regarding platelets. The proposed randomized trial is intended to resolve debate and uncertainty regarding optimum blood product ratios.

Study Design: Randomized, two-group, controlled Phase III trial with a Vanguard stage. Equal random allocation to treatment using stratified, permuted blocks with randomly chosen block sizes and stratification by site.

Objective: To conduct a Phase III multi-site, randomized trial in subjects predicted to have a massive transfusion, comparing the efficacy and safety of 1:1:1 transfusion ratios of plasma and platelets to red blood cells (the closest approximation to reconstituted whole blood) with the 1:1:2 ratio. The co-primary outcomes will be 24-hour and 30-day mortality. The PROPPR Trial will be conducted with exception from informed consent (EFIC). Additionally, laboratory data from the trial will add to the understanding of trauma induced coagulopathy (TIC) and inflammation.

Conditions
Trauma
Being tested
1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Keywords
Massive Transfusion, Trauma, Coagulopathy, Trauma Induced Coagulopathy, Plasma, Platelets, Red Blood Cells, Mortality, Wounds and Injuries, Shock, Hemorrhagic, Shock, Pathologic Processes, Hemorrhage, Hemostatics, Coagulation, Transfusion-related acute lung injury (TRALI), Inflammation
Medical subject headings
Wounds and Injuries, Hemostatic Disorders, Shock, Hemorrhagic, Shock, Pathologic Processes, Hemorrhage, Thrombosis, Transfusion-Related Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1:1:1 Blood Transfusion RatioBiological

    Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.

  • 1:1:2 Blood Transfusion RatioBiological

    Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.

Study groups in NCT01545232
Study groupRoleWhat they receive
1:1:1 Blood Transfusion RatioActive comparatorNot described
Receives: Biological: 1:1:1 Blood Transfusion Ratio
1:1:2 Blood Transfusion RatioActive comparatorNot described
Receives: Biological: 1:1:2 Blood Transfusion Ratio

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-hour Mortality

    Measured: First 24 hours after ED admission

  2. 30-day Mortality

    Measured: First 30 days after ED admission

  3. Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE)

    Blood samples were collected at time of ED admission and over time to determine the incidence of reported venous thrombolic events (VTE).

    Measured: From time of ED admission, for up to 72 hours

Secondary outcomes (10)

  1. Hospital Free Days

    Measured: first 30 days after ED admission

  2. Time to Hemostasis

    Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival.

    Measured: ED admission to hospital discharge or 30 days, whichever comes first

  3. Amount of Randomized Blood Products Given to Hemostasis

    Measured: 24 hours from randomization

  4. Functional Status at Time of Hospital Discharge

    The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.

    Measured: Hospital discharge or 30 days, whichever comes first

  5. Incidence of Primary Surgical Procedure

    Measured: ED admission to hospital discharge or 30 days, whichever comes first

  6. Incidence of Transfusion Related Serious Adverse Events

    Measured: ED admission to hospital discharge or 30 days, whichever comes first

  7. Initial Hospital Discharge Status

    Measured: Hospital discharge or 30 days, whichever comes first

  8. Ventilator Free Days

    Measured: first 30 days after ED admission

  9. ICU Free Days

    Measured: first 30 days after ED admission

  10. Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission

    Measured: 24 hours after ED admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
680 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01545232
Sponsor's protocol ID
HSC-GEN-11-0174
Other IDs
U01HL077863
Acronym
PROPPR
Status last verified
Feb 2019
First submitted
29 Feb 2012
Last updated
8 Feb 2019
Data monitoring committee
Yes

Publications

  • Baird EW, Lammers DT, Abraham PJ, Hashmi ZG, Griffin RL, Stephens SW, Jansen JO, Holcomb JB. Outcomes of patients enrolled in a prospective and randomized trial on basis of gestalt assessment or ABC score. J Trauma Acute Care Surg. 2024 Jun 1;96(6):876-881. doi: 10.1097/TA.0000000000004276. Epub 2024 Feb 12.

    PubMed 38342992

  • Levy DT, Livingston CE, Saroukhani S, Fox EE, Wade CE, Holcomb JB, Gumbert SD, Galvagno SM Jr, Kaslow OY, Pittet JF, Pivalizza EG. Association of Opioid Administration During General Anesthesia and Survival for Severely Injured Trauma Patients: A Preplanned Secondary Analysis of the PROPPR Study. Anesth Analg. 2023 May 1;136(5):905-912. doi: 10.1213/ANE.0000000000006456. Epub 2023 Apr 14.

    PubMed 37058726

  • McCully BH, Wade CE, Fox EE, Inaba K, Cohen MJ, Holcomb JB, Schreiber MA; PROPPR study group. Temporal profile of the pro- and anti-inflammatory responses to severe hemorrhage in patients with venous thromboembolism: Findings from the PROPPR trial. J Trauma Acute Care Surg. 2021 May 1;90(5):845-852. doi: 10.1097/TA.0000000000003088.

    PubMed 33797501

  • DeSantis SM, Brown DW, Jones AR, Yamal JM, Pittet JF, Patel RP, Wade CE, Holcomb JB, Wang H; PROPPR Study Group. Characterizing red blood cell age exposure in massive transfusion therapy: the scalar age of blood index (SBI). Transfusion. 2019 Aug;59(8):2699-2708. doi: 10.1111/trf.15334. Epub 2019 May 3.

    PubMed 31050809

  • Jones AR, Patel RP, Marques MB, Donnelly JP, Griffin RL, Pittet JF, Kerby JD, Stephens SW, DeSantis SM, Hess JR, Wang HE; PROPPR Study Group. Older Blood Is Associated With Increased Mortality and Adverse Events in Massively Transfused Trauma Patients: Secondary Analysis of the PROPPR Trial. Ann Emerg Med. 2019 Jun;73(6):650-661. doi: 10.1016/j.annemergmed.2018.09.033. Epub 2018 Nov 15.

    PubMed 30447946

  • Cardenas JC, Zhang X, Fox EE, Cotton BA, Hess JR, Schreiber MA, Wade CE, Holcomb JB; PROPPR Study Group. Platelet transfusions improve hemostasis and survival in a substudy of the prospective, randomized PROPPR trial. Blood Adv. 2018 Jul 24;2(14):1696-1704. doi: 10.1182/bloodadvances.2018017699.

    PubMed 30030268

  • Henry B, Perez A, Trpcic S, Rizoli S, Nascimento B. Protecting study participants in emergency research: is community consultation before trial commencement enough? Trauma Surg Acute Care Open. 2017 Jul 12;2(1):e000084. doi: 10.1136/tsaco-2017-000084. eCollection 2017.

    PubMed 29766088

  • Galvagno SM Jr, Fox EE, Appana SN, Baraniuk S, Bosarge PL, Bulger EM, Callcut RA, Cotton BA, Goodman M, Inaba K, O'Keeffe T, Schreiber MA, Wade CE, Scalea TM, Holcomb JB, Stein DM; PROPPR Study Group. Outcomes after concomitant traumatic brain injury and hemorrhagic shock: A secondary analysis from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios trial. J Trauma Acute Care Surg. 2017 Oct;83(4):668-674. doi: 10.1097/TA.0000000000001584. Epub 2017 Jun 6.

    PubMed 28930959

  • Naumann DN, Vincent LE, Pearson N, Beaven A, Smith IM, Smith K, Toman E, Dorrance HR, Porter K, Wade CE, Cotton BA, Holcomb JB, Midwinter MJ. An adapted Clavien-Dindo scoring system in trauma as a clinically meaningful nonmortality endpoint. J Trauma Acute Care Surg. 2017 Aug;83(2):241-248. doi: 10.1097/TA.0000000000001517.

    PubMed 28731937

  • Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.

    PubMed 25647203

  • Baraniuk S, Tilley BC, del Junco DJ, Fox EE, van Belle G, Wade CE, Podbielski JM, Beeler AM, Hess JR, Bulger EM, Schreiber MA, Inaba K, Fabian TC, Kerby JD, Cohen MJ, Miller CN, Rizoli S, Scalea TM, O'Keeffe T, Brasel KJ, Cotton BA, Muskat P, Holcomb JB; PROPPR Study Group. Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: design, rationale and implementation. Injury. 2014 Sep;45(9):1287-95. doi: 10.1016/j.injury.2014.06.001. Epub 2014 Jun 10.

    PubMed 24996573

  • Lissauer ME, Galvagno SM Jr, Rock P, Narayan M, Shah P, Spencer H, Hong C, Diaz JJ. Increased ICU resource needs for an academic emergency general surgery service*. Crit Care Med. 2014 Apr;42(4):910-7. doi: 10.1097/CCM.0000000000000099.

    PubMed 24335442

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 1:1:1 Blood Transfusion Ratio and 1:1:2 Blood Transfusion Ratio in people with Trauma, run by The University of Texas Health Science Center, Houston at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour Mortality (time frame: First 24 hours after ED admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01545232, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.

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PROPPR Clinical Trial NCT01545232 | AzTrials