The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Donato
• Collaborator: CSL Behring
• Treatments: Thrombin

Criteria

Inclusion Criteria:

• 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)

1. Combined cardiac operation with expected CPB duration > 90 minutes

2. At least one additional risk factor within the following: Age > 65 years; Non elective surgery; Serum creatinine > 1.36 mg/dL; Redo operation

Exclusion Criteria:

1. Age < 18 years

2. Patients under thienopyridines

3. Known coagulopathy

4. Known autoimmune disorders

5. Participation in another RCT

6. Pregnancy

7. Emergency operation

8. Baseline HCT < 35%

9. Baseline Antithrombin < 80%

10. BSA < 1.7 m2

WITHDRAWAL CRITERION:

1. Lowest HCT on CPB < 23%

2. Transfusions during CPB

• Patients randomized and not withdrawn will be DOSED with the investigational drugs.