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)

Heinrich-Heine University, Duesseldorf1 site in 1 countryJanuary 2008

ConditionsBlood Loss, Surgical

InterventionsHaemate HS NaCl-solution

DrugsHaemate HS

Overview

Phase: Phase 2
Intervention: Haemate HS
Conditions: Blood Loss, Surgical
Sponsor: Heinrich-Heine University, Duesseldorf
Locations: 1
Primary Endpoint: intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds
Status: Withdrawn
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

July 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

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

Arms & Interventions

1

intravenous infusion of Haemate (dosage dependent on body weight)

Intervention: Haemate HS

2

intravenous infusion of 0.9% NaCl solution

Intervention: NaCl-solution

Outcomes

Primary Outcomes

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