Status:
COMPLETED
The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery
Lead Sponsor:
IRCCS Policlinico S. Donato
Collaborating Sponsors:
CSL Behring
Conditions:
Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 comple...
Detailed Description
Study design Randomized, placebo-controlled, double-blinded study Endpoints Primary: Transfusion avoidance of every allogeneic blood product Secondary: Reduction in the number of allogeneic blood prod...
Eligibility Criteria
Inclusion
- The patients will be screened according to a modified TRUST1 Transfusion Score. This score attributes 1 point to each of the following conditions:
- Hb level \< 13.5 g/dL
- Weight \< 77 kg
- Female sex
- Age \> 65 years
- Non elective surgery
- Serum creatinine \> 1.36 mg/dL
- Redo operation
- Non isolated surgery
- Factors are hemodilution-related factors, and will not be included. Non isolated surgery is mandatory for inclusion. Patients will be included in presence of at least 1 within the remaining 4 risk factors:
- Age \> 65 years
- Non elective surgery
- Serum creatinine \> 1.36 mg/dL '8Redo operation INCLUSION CRITERIA (patients randomized)
- Combined cardiac operation with expected CPB duration \> 90 minutes
- At least one additional risk factor within the following: Age \> 65 years; Non elective surgery; Serum creatinine \> 1.36 mg/dL; Redo operation
Exclusion
- Age \< 18 years
- Patients under thienopyridines
- Known coagulopathy
- Known autoimmune disorders
- Participation in another RCT
- Pregnancy
- Emergency operation
- Baseline HCT \< 35%
- Baseline Antithrombin \< 80%
- BSA \< 1.7 m2
- WITHDRAWAL CRITERION:
- Lowest HCT on CPB \< 23%
- Transfusions during CPB
- Patients randomized and not withdrawn will be DOSED with the investigational drugs.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT01471730
Start Date
November 1 2011
End Date
December 1 2014
Last Update
March 31 2015
Active Locations (1)
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1
IRCCS Policlinico San Donato
San Donato Milanese, MI, Italy, 20097