Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR)

This study has been completed.
Sponsor:
Collaborators:
Resuscitation Outcomes Consortium
Defence Research and Development Canada
Information provided by (Responsible Party):
John Holcomb, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01545232
First received: February 29, 2012
Last updated: May 29, 2015
Last verified: May 2015
Results First Received: April 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Trauma
Interventions: Biological: 1:1:1 Blood Transfusion Ratio
Biological: 1:1:2 Blood Transfusion Ratio

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1:1:1 Blood Transfusion Ratio 1:1:1 Blood Transfusion Ratio: 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 Ratio 1:1:2 Blood Transfusion Ratio: 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.

Participant Flow:   Overall Study
    1:1:1 Blood Transfusion Ratio     1:1:2 Blood Transfusion Ratio  
STARTED     338     342  
COMPLETED     338     342  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1:1:1 Blood Transfusion Ratio 1:1:1 Blood Transfusion Ratio: 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 Ratio 1:1:2 Blood Transfusion Ratio: 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.
Total Total of all reporting groups

Baseline Measures
    1:1:1 Blood Transfusion Ratio     1:1:2 Blood Transfusion Ratio     Total  
Number of Participants  
[units: participants]
  338     342     680  
Age, Customized [1]
[units: participants]
  338     342     680  
Gender  
[units: participants]
     
Female     75     59     134  
Male     263     283     546  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     61     59     120  
Not Hispanic or Latino     277     283     560  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     6     2     8  
Asian     21     8     29  
Native Hawaiian or Other Pacific Islander     3     1     4  
Black or African American     93     93     186  
White     210     224     434  
More than one race     2     0     2  
Unknown or Not Reported     3     14     17  
[1] 15 years of age or older



  Outcome Measures
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1.  Primary:   24-hour Mortality   [ Time Frame: First 24 hours after ED admission ]

2.  Primary:   30-day Mortality   [ Time Frame: First 30 days after ED admission ]

3.  Secondary:   Hospital Free Days   [ Time Frame: first 30 days after ED admission ]

4.  Secondary:   Time to Hemostasis   [ Time Frame: ED admission to hospital discharge or 30 days, whichever comes first ]

5.  Secondary:   Amount of Randomized Blood Products Given to Hemostasis   [ Time Frame: 24 hours from randomization ]

6.  Secondary:   Functional Status at Time of Hospital Discharge   [ Time Frame: Hospital discharge or 30 days, whichever comes first ]

7.  Secondary:   Incidence of Primary Surgical Procedure   [ Time Frame: ED admission to hospital discharge or 30 days, whichever comes first ]

8.  Secondary:   Incidence of Transfusion Related Serious Adverse Events   [ Time Frame: ED admission to hospital discharge or 30 days, whichever comes first ]

9.  Secondary:   Initial Hospital Discharge Status   [ Time Frame: Hospital discharge or 30 days, whichever comes first ]

10.  Secondary:   Ventilator Free Days   [ Time Frame: first 30 days after ED admission ]

11.  Secondary:   ICU Free Days   [ Time Frame: first 30 days after ED admission ]

12.  Secondary:   Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission   [ Time Frame: 24 hours after ED admission ]

13.  Primary:   Coagulation and Inflammatory Phenotypes at Emergency Department Admission and Over Time.   [ Time Frame: 72 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Holcomb, M.D.
Organization: University of Texas Health Science Center - Houston
phone: 713-500-5493
e-mail: John.Holcomb@uth.tmc.edu


No publications provided by The University of Texas Health Science Center, Houston

Publications automatically indexed to this study:

Responsible Party: John Holcomb, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01545232     History of Changes
Other Study ID Numbers: HSC-GEN-11-0174, U01HL077863
Study First Received: February 29, 2012
Results First Received: April 22, 2015
Last Updated: May 29, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board