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

Primary Purpose

Blood Loss, Surgical

Status
Withdrawn
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Haemate HS
NaCl-solution
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss, Surgical focused on measuring intraoperative bleeding, aortic-valve replacement, aortic stenosis, Von Willebrand, HEAMATE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Kardiovaskuläre Chirurgie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

intravenous infusion of Haemate (dosage dependent on body weight)

intravenous infusion of 0.9% NaCl solution

Outcomes

Primary Outcome Measures

intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds

Secondary Outcome Measures

Assessment of adverse events and viral safety

Full Information

First Posted
February 8, 2008
Last Updated
January 3, 2012
Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT00618293
Brief Title
Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis
Acronym
HAVAS
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No patient met the criteria for inclusion in the study.
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
CSL Behring

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
Keywords
intraoperative bleeding, aortic-valve replacement, aortic stenosis, Von Willebrand, HEAMATE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
intravenous infusion of Haemate (dosage dependent on body weight)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
intravenous infusion of 0.9% NaCl solution
Intervention Type
Drug
Intervention Name(s)
Haemate HS
Intervention Description
intravenous infusion of Haemate (dosage dependent on body weight)
Intervention Type
Other
Intervention Name(s)
NaCl-solution
Intervention Description
intravenous infusion of 0.9%NaCl-Solution
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assessment of adverse events and viral safety
Time Frame
1.perioperative 2. during hospital admission 3. within 90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 emergency surgery within the last 7 days weight < 50 kg and > 100 kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Feindt, Prof. Dr. med.
Organizational Affiliation
Klinik für Kardiovaskuläre Chirurgie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Kardiovaskuläre Chirurgie
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany

12. IPD Sharing Statement

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

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