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

This study has been completed.
CSL Behring
Information provided by (Responsible Party):
Marco Ranucci, IRCCS Policlinico S. Donato Identifier:
First received: November 7, 2011
Last updated: March 29, 2015
Last verified: March 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 Intervention Phase
Heart Disease
Drug: Fibrinogen
Drug: Saline solution
Drug: Prothrombin complex
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by IRCCS Policlinico S. Donato:

Primary Outcome Measures:
  • Avoidance of allogeneic blood products transfusion [ Time Frame: 30 days ]
    Includes avoidance of packed red cells, FFP, platelet concentrates, cryoprecipitates

Secondary Outcome Measures:
  • 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.

Enrollment: 119
Study Start Date: November 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline solution Drug: Saline solution
Normal saline will be administered to control patients.
Other Name: Placebo
Active Comparator: Fibrinogen Drug: 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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  1. Lowest HCT on CPB < 23%
  2. Transfusions during CPB

    • Patients randomized and not withdrawn will be DOSED with the investigational drugs.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01471730

IRCCS Policlinico San Donato
San Donato Milanese, MI, Italy, 20097
Sponsors and Collaborators
IRCCS Policlinico S. Donato
CSL Behring
Principal Investigator: Marco Ranucci, MD IRCCS Policlinico San Donato
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Marco Ranucci, Director of Clinical Research in the Department of the Anesthesia and Intensive care, IRCCS Policlinico S. Donato Identifier: NCT01471730     History of Changes
Other Study ID Numbers: 7-020-MR
2011-005223-40 ( EudraCT Number )
Study First Received: November 7, 2011
Last Updated: March 29, 2015

Keywords provided by IRCCS Policlinico S. Donato:
Fresh Frozen Plasma
Prothrombin complex

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Coagulants processed this record on April 28, 2017