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1:1:1 Blood Transfusion Ratio

Phase 3

Trauma | Monoclonal antibody | Musculoskeletal |United Therapeutics Corporation|Last Updated: Feb 8, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment680

FDA Designations

No designations recorded

Clinical trial landscape

1:1:1 Blood Transfusion Ratio · 1 trial · 1 indication

Phase 3 1
NCT01545232Pragmatic, Randomized Optimal Platelet and Plasma RatiosTrauma
COMPLETED680 Analytics
PHASE3COMPLETED
Pragmatic, Randomized Optimal Platelet and Plasma Ratios
TraumaUnlock trial analytics

Study Endpoints

Primary Endpoints

24-hour Mortality
First 24 hours after ED admission
30-day Mortality
First 30 days after ED admission
Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE)
From time of ED admission, for up to 72 hours

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

Secondary Endpoints

Hospital Free Days
first 30 days after ED admission
Time to Hemostasis
ED admission to hospital discharge or 30 days, whichever comes first
Amount of Randomized Blood Products Given to Hemostasis
24 hours from randomization
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1:1:1 Blood Transfusion RatioACTIVE_COMPARATOR -
1:1:2 Blood Transfusion RatioACTIVE_COMPARATOR -

Interventions

NameTypeDescription
1:1:1 Blood Transfusion RatioBIOLOGICALGroup 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 RatioBIOLOGICALGroup 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.
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Eligibility Criteria

Age Range15 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * 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 ...

Countries:United StatesCanada
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Competitive Landscape -Trauma and Injury 8 trials (matched to "Trauma")

Frequently asked questions about 1:1:1 Blood Transfusion Ratio

What is the 1:1:1 Blood Transfusion Ratio used for in trauma?

The 1:1:1 Blood Transfusion Ratio is a transfusion strategy being studied for use in trauma patients. It involves administering platelets, plasma, and red blood cells in equal ratios to manage severe bleeding. The approach is under investigation as a treatment for trauma-related hemorrhage.

Who is developing the 1:1:1 Blood Transfusion Ratio?

The 1:1:1 Blood Transfusion Ratio is being developed by United Therapeutics Corporation, a company traded on the NASDAQ under the ticker UTHR. The company is conducting clinical research to evaluate this transfusion strategy in trauma patients.

What phase is the 1:1:1 Blood Transfusion Ratio in?

The 1:1:1 Blood Transfusion Ratio is in Phase 3 clinical development. It is an investigational transfusion strategy, not yet approved by regulatory authorities. The Phase 3 trial has been completed, and the strategy remains under clinical investigation for trauma.

What clinical trials is the 1:1:1 Blood Transfusion Ratio in?

The 1:1:1 Blood Transfusion Ratio was evaluated in a Phase 3 clinical trial registered as NCT01545232, titled 'Pragmatic, Randomized Optimal Platelet and Plasma Ratios.' This completed trial enrolled 680 participants with trauma in the United States and Canada.

Is the 1:1:1 Blood Transfusion Ratio a randomized controlled trial?

Yes, the 1:1:1 Blood Transfusion Ratio was studied in a randomized, active-controlled clinical trial. The trial was not double-blinded, and it compared the 1:1:1 ratio strategy against an active control. The study enrolled 680 trauma patients and has been completed.