Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis (HAVAS)

January 3, 2012 updated by: Heinrich-Heine University, Duesseldorf

Phase 2 Study in Evaluation of the Efficacy and Safety of Haemate HS in This Clinical Setting (Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis)

Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Klinik für Kardiovaskuläre Chirurgie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement
  • Caucasian
  • written informed consent (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.Classification as excessive leads to recruitment)

Exclusion Criteria:

  • active endocarditis
  • history suggestive for inherited oe acquired bleeding disorder
  • concomitant coronary heart disease
  • agents impairing platelet function up to 14 days before surgery
  • Pregnancy
  • inherited platelet function
  • known intolerance against HAEMATE HS
  • previous thromboembolic complications
  • Hepatitis B, C or HIV infection
  • previous chemotherapy
  • emergency surgery within the last 7 days
  • weight < 50 kg and > 100 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
intravenous infusion of Haemate (dosage dependent on body weight)
Drug: Haemate HS
intravenous infusion of Haemate (dosage dependent on body weight)
Placebo Comparator: 2
intravenous infusion of 0.9% NaCl solution
Other: NaCl-solution
intravenous infusion of 0.9%NaCl-Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds
Time Frame: begin of surgery and 48h after administration of medication
begin of surgery and 48h after administration of medication

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of adverse events and viral safety
Time Frame: 1.perioperative 2. during hospital admission 3. within 90 days after surgery
1.perioperative 2. during hospital admission 3. within 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

CSL Behring

Investigators

  • Principal Investigator: Peter Feindt, Prof. Dr. med., Klinik für Kardiovaskuläre Chirurgie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 3, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BI8021_5101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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