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

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. Identifier: NCT00618293
Recruitment Status : Withdrawn (No patient met the criteria for inclusion in the study.)
First Posted : February 20, 2008
Last Update Posted : January 5, 2012
CSL Behring
Information provided by:
Heinrich-Heine University, Duesseldorf

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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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)
Study Start Date : January 2008
Estimated Primary Completion Date : July 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00618293

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

Responsible Party: Heinrich-Heine University, represented by Principal investigator Prof. Feindt, Department of Hemostasis and Transfusion Medicine Identifier: NCT00618293     History of Changes
Other Study ID Numbers: BI8021_5101
First Posted: February 20, 2008    Key Record Dates
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

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