The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery (ZEPLAST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01471730|
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : March 31, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease||Drug: Fibrinogen Drug: Saline solution Drug: Prothrombin complex||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The ZEroPLASmaTrial (ZEPLAST): a Randomized, Controlled Trial on Transfusion Avoidance in High Transfusion-risk Cardiac Surgery Patients|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|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All the patients randomized and not withdrawn will be tested 20 minutes before removal of aortic cross clamping with a Thromboelastometric fibrinogen test FIBTEM (Rotem) .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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471730
|IRCCS Policlinico San Donato|
|San Donato Milanese, MI, Italy, 20097|
|Principal Investigator:||Marco Ranucci, MD||IRCCS Policlinico San Donato|