Haemate HS in Patients With Severe Bleeding Undergoing Va... | NCT00618293

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

NCT00618293

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Withdrawn

Last Update Posted

Jan 5, 2012Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Blood Loss, Surgical

Interventions

Haemate HS
NaCl-solution

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patient met the criteria for inclusion in the study.

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jul 2010Estimated

Completion Date

Jul 2011Actual

First Submitted Date

Feb 8, 2008

First Submission Date that Met QC Criteria

Feb 8, 2008

First Posted Date

Feb 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2012

Last Update Posted Date

Jan 5, 2012Estimated

Name	Class
CSL Behring	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	intravenous infusion of Haemate (dosage dependent on body weight)	Drug: Haemate HS
2	Placebo Comparator	intravenous infusion of 0.9% NaCl solution	Other: NaCl-solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Haemate HS	Drug	intravenous infusion of Haemate (dosage dependent on body weight)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds		begin of surgery and 48h after administration of medication

Secondary Outcomes

Measure	Description	Time Frame
Assessment of adverse events and viral safety		1.perioperative 2. during hospital admission 3. within 90 days after surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Feindt, Prof. Dr. med.	Klinik für Kardiovaskuläre Chirurgie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Kardiovaskuläre Chirurgie		Düsseldorf		40225	Germany

Condition Browse Module

MeSH Terms

ID	Term
D016063	Blood Loss, Surgical
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007431	Intraoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided