NCT00151853

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

December 7, 2023

Status Verified

January 1, 2006

First QC Date

September 8, 2005

Last Update Submit

December 6, 2023

Conditions

CPBOral Anticoagulant Therapy

Keywords

CPBoral anticoagulant therapyplasmaPCC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

PPSB-SDDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

Study Officials

  • P FW Strengers, MD

    Prothya Biosolutions

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

March 1, 2002

Study Completion

September 1, 2004

Last Updated

December 7, 2023

Record last verified: 2006-01

Locations

BE(1)