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

This study has been withdrawn prior to enrollment.
(No patient met the criteria for inclusion in the study.)
Sponsor:
Collaborator:
CSL Behring
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00618293
First received: February 8, 2008
Last updated: January 3, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Blood Loss, Surgical
 Drug: Haemate HS
Other: NaCl-solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of adverse events and viral safety [ Time Frame: 1.perioperative 2. during hospital admission 3. within 90 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2008
Study Completion Date: July 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • emergency surgery within the last 7 days
  • weight < 50 kg and > 100 kg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618293

Locations
Germany
Klinik für Kardiovaskuläre Chirurgie
Düsseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
CSL Behring
Investigators
Principal Investigator: Peter Feindt, Prof. Dr. med. Klinik für Kardiovaskuläre Chirurgie
  More Information

No publications provided

Responsible Party: Heinrich-Heine University, represented by Principal investigator Prof. Feindt, Department of Hemostasis and Transfusion Medicine
ClinicalTrials.gov Identifier: NCT00618293     History of Changes
Other Study ID Numbers: BI8021_5101
Study First Received: February 8, 2008
Last Updated: January 3, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Heinrich-Heine University, Duesseldorf:
intraoperative bleeding
aortic-valve replacement
aortic stenosis
Von Willebrand
HEAMATE

Additional relevant MeSH terms:
Aortic Valve Stenosis
Hemorrhage
Blood Loss, Surgical
Heart Valve Diseases
Heart Diseases
 Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathologic Processes
Intraoperative Complications

ClinicalTrials.gov processed this record on June 17, 2013