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

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)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00618293

Acronym

HAVAS

Enrollment

Registered

2008-02-20

Start date

2008-01-31

Completion date

2011-07-31

Last updated

2012-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Surgical

Keywords

intraoperative bleeding, aortic-valve replacement, aortic stenosis, Von Willebrand, HEAMATE

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).

Interventions

DRUGHaemate HS

intravenous infusion of Haemate (dosage dependent on body weight)

OTHERNaCl-solution

intravenous infusion of 0.9%NaCl-Solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026