Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Sanquin
ClinicalTrials.gov Identifier:
NCT00151853
First received: September 8, 2005
Last updated: January 30, 2006
Last verified: January 2006
History of Changes
  Purpose

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
CPB
Oral Anticoagulant Therapy
 Drug: PPSB-SD
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151853

Locations
Belgium
University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Sanquin
Investigators
Study Director: P FW Strengers, MD Sanquin
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00151853     History of Changes
Other Study ID Numbers: CAF2001.01
Study First Received: September 8, 2005
Last Updated: January 30, 2006
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Sanquin:
CPB
oral anticoagulant therapy
plasma
PCC

Additional relevant MeSH terms:
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013