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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00618293
First Posted: February 20, 2008
Last Update Posted: January 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CSL Behring
Information provided by:
Heinrich-Heine University, Duesseldorf
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:


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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 8, 2008
First Posted: February 20, 2008
Last Update Posted: January 5, 2012
Last Verified: January 2012

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

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