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Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery

This study has been completed.
Information provided by:
Sanquin Identifier:
First received: September 8, 2005
Last updated: January 30, 2006
Last verified: January 2006
The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (CPB).

Condition Intervention Phase
Oral Anticoagulant Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study on the Efficacy of PPSB-SD and VP-VI in Patients Using Oral Anticoagulant Therapy and Undergoing Acute Cardiac Surgery With a Cardiopulmonary Bypass

Resource links provided by NLM:

Further study details as provided by Sanquin:

Primary Outcome Measures:
  • The primary objective of this study was to determine the mean time, median time and difference in time needed to reach the target INR of ≤1.5 after the end of CPB.

Secondary Outcome Measures:
  • The secondary objective of this study was to compare the number of post-(cpb)operative bleedings or re-operations for bleedings as well as the difference in the need of blood transfusions between the two groups

Estimated Enrollment: 40
Study Start Date: March 2002
Estimated Study Completion Date: September 2004
Detailed Description:
The value of oral anticoagulants such as coumarin derivatives as a therapy and in the prophylaxis of thrombosis is universally acknowledged. These medicinal products are used in the prevention of cerebral infarction, in patients with atrial fibrillation and in the secondary prevention of myocardial infarction. In case of elected surgery, the effect of coumarin derivatives can be reversed by a termination of the coumarin treatment and the administration of vitamin K orally, i.m. or i.v., which will restore the production of the vitamin K dependent coagulation factors. For patients due to undergo acute surgery, it will be unfavourable to await endogenous production of vitamin K dependent coagulation factor production.After CPB surgery, the patients need to be in a controlled coagulated state. Two products suitable to rapidly increase the concentration of vitamin K dependent coagulation factors, are fresh frozen plasma (FFP) and prothrombin complex concentrates (PCC). These products contain factor II, VII, IX and X and help to restore normal levels of the clotting fraction.Administration of these products prior to CPB surgery will decrease the INR to a level that is acceptable for surgery. In the Academic Hospital Leuven the standard procedure in cases of acute and elected CPB surgery is administration of VP-VI, a FFP-product made by OCTAPHARMA. In this study the standard treatment of 2x 400 ml VP-VI was compared with a treatment of PPSB Solvent Detergent® (PPSB-SD) according to the prescription regimen of CAF-DCF. PPSB-SD is a PCC product made by Sanquin Plasma Products (the Netherlands) for CAF-DCF (Belgium). The regimen as prescribed by CAF-DCF enables to calculate the quantity of PPSB-SD to administer on the basis of the patient’s weight, the initial INR and the target INR. The expected outcome of the study was that in patients receiving PPSB-SD the target INR will be reached more frequently and more rapidly compared to patients receiving VP-VI.

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

Inclusion Criteria:

age at least 18 years and due to undergo (semi-) acute cardiac surgery with a relatively stable haemodynamic condition.

and body weight less than 100 kg and informed consent and patients well controlled with acenocoumarol, phenprocoumon or warfarin.

Exclusion Criteria:

patients with an overdose of acenocoumarol, phenprocoumon or warfarin (INR > 7.8) and due to undergo (semi-) acute cardiac surgery hepatic insufficiency renal insufficiency anaphylactic reaction after administration of a blood product in the past disseminated intravascular coagulation (DIC) active thrombosis/pulmonary embolism intracardial thrombus patients treated with platelet inhibitors, except for aspirin (acetylsalicylic acid), who will be treated with aprotinine pregnancy breast-feeding

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Please refer to this study by its identifier: NCT00151853

University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Study Director: P FW Strengers, MD Sanquin
  More Information Identifier: NCT00151853     History of Changes
Other Study ID Numbers: CAF2001.01
Study First Received: September 8, 2005
Last Updated: January 30, 2006

Keywords provided by Sanquin:
oral anticoagulant therapy

Additional relevant MeSH terms:
Anticoagulants processed this record on April 26, 2017