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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. Identifier: NCT01471730
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : March 31, 2015
CSL Behring
Information provided by (Responsible Party):
Marco Ranucci, IRCCS Policlinico S. Donato

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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All the patients randomized and not withdrawn will be tested 20 minutes before removal of aortic cross clamping with a Thromboelastometric fibrinogen test FIBTEM (Rotem) .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

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

Secondary Outcome Measures :
  1. Reduction in allogeneic blood products transfusions [ Time Frame: 30 days ]
  2. 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.

  3. Bleeding [ Time Frame: First postoperative 12 hours ]
    Amount of postoperative bleeding that the patients experience in the first postoperative 12 hours.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01471730

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


Publications automatically indexed to this study by Identifier (NCT Number):
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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 )
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Marco Ranucci, IRCCS Policlinico S. Donato:
Fresh Frozen Plasma
Prothrombin complex
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases