The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery (ZEPLAST)
Prospective, randomized, double blind trial. The rationale of the study is the concept that fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that prothrombin complexes and fibrinogen are available.The experimental hypothesis is that cardiac surgery patients may be operated with no use of FFP and with a coagulation factors replacement based on fibrinogen and prothrombin complexes (when needed).
Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive blood transfusion, bleeding.
Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60 patients each
|Heart Disease||Drug: Fibrinogen Drug: Saline solution Drug: Prothrombin complex||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The ZEroPLASmaTrial (ZEPLAST): a Randomized, Controlled Trial on Transfusion Avoidance in High Transfusion-risk Cardiac Surgery Patients|
- Avoidance of allogeneic blood products transfusion [ Time Frame: 30 days ]Includes avoidance of packed red cells, FFP, platelet concentrates, cryoprecipitates
- Reduction in allogeneic blood products transfusions [ Time Frame: 30 days ]
- Massive blood transfusion [ Time Frame: First postoperative 24 hours ]Number of patients experiencing blood transfusion of 7 RBC units or more in the first postoperative 24 hours.
- Bleeding [ Time Frame: First postoperative 12 hours ]Amount of postoperative bleeding that the patients experience in the first postoperative 12 hours.
|Study Start Date:||November 2011|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Saline solution||
Drug: Saline solution
Normal saline will be administered to control patients.
Other Name: Placebo
|Active Comparator: Fibrinogen||
All the patients randomized and not withdrawn will be tested 20 minutes before removal of aortic cross clamping with a Thromboelastometric fibrinogen test FIBTEM (Rotem) . They will all receive either human fibrinogen concentrate (according to the formula: (22 [mm] − MCF [mm]) * body weight [kg] / 140 [m] = whole g fibrinogen to be dosed as HFC) (treatment group) or placebo (control group). Study drug or placebo has to be administered after protamine.
Other Name: RIASTAP
|Active Comparator: Prothrombin complex||
Drug: Prothrombin complex
After 15min from study drug administration and in presence of ongoing microvascular bleeding, we run a CT EXTEM. In case of prolonged CT time at EXTEM as long as 80 seconds [M1] , they will receive coagulation factors concentrates (Confidex) at a weight-based dose of 7 U/kg b.w. (treatment group) or placebo.
Other Name: CONFIDEX
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01471730
|IRCCS Policlinico San Donato|
|San Donato Milanese, MI, Italy, 20097|
|Principal Investigator:||Marco Ranucci, MD||IRCCS Policlinico San Donato|