Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis - Full Text View

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

This study is currently recruiting participants.

Verified by Heinrich-Heine University, Duesseldorf, February 2008

First Received: February 8, 2008 No Changes Posted

Sponsored by:	Heinrich-Heine University, Duesseldorf
Information provided by:	Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:	NCT00618293

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 II

MedlinePlus related topics: Blood Transfusion and Donation Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

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 ]

Estimated Enrollment:	40
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator intravenous infusion of Haemate (dosage dependent on body weight)	Drug: Haemate HS intravenous infusion of Haemate (dosage dependent on body weight)
2: Placebo Comparator 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

Contacts

Contact: Rainer Zotz, PD Dr.

0049-2118117237

zotz@med.uni-duesseldorf.de

Locations

Germany, NW
Heinrich-Heine University University Hospital Department of Thoracic and Cardiovascular Surgery	Recruiting
Duesseldorf, NW, Germany, 40225
Contact: P. Feindt, Prof. Dr. 0049-211-8118879 peter.feindt@uni-duesseldorf.de
Sub-Investigator: P. Feindt, Prof. Dr.
Sub-Investigator: U. Boecken, PD Dr.

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

Principal Investigator:

Rainer Zotz, PD Dr.

Institute of Hemostasis and Transfusion Medicine

More Information

No publications provided

Responsible Party:	Department of Hemostasis and Transfusion Medicine ( Heinrich-Heine University, represented by Principal investigator PD Dr. Rainer Zotz )
Study ID Numbers:	BI8021_5101
Study First Received:	February 8, 2008
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00618293 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Heinrich-Heine University, Duesseldorf:

intraoperative bleeding
aortic-valve replacement
aortic stenosis
Von Willebrand
HEAMATE

Study placed in the following topic categories:

Heart Diseases
Constriction, Pathologic
Blood Loss, Surgical
Intraoperative Complications

Hemorrhage
Aortic Valve Stenosis
Heart Valve Diseases

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Blood Loss, Surgical
Intraoperative Complications

Hemorrhage
Aortic Valve Stenosis
Ventricular Outflow Obstruction
Heart Valve Diseases

ClinicalTrials.gov processed this record on May 07, 2009