BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

• To determine the therapeutic window of BIBR 1048 in order to select doses for further studies in the development plan.

• Twice daily regimen will be tested for most dose levels and once daily administration will also be evaluated when appropriate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran

Criteria

Inclusion Criteria:

• Patients scheduled to undergo a primary elective total hip replacement

• Male of female being 18 years or older

• Patients weighing at least 40 kg

• Written informed consent for study participation

Exclusion Criteria:

• Bleeding diathesis, constitutional or acquired coagulation disorders

• Major surgery or trauma (e.g. hip fracture) within the last three months. Patients with previous hip fractures associated with plate revisions at any time will be excluded

• Cardiovascular disease including uncontrolled hypertension at time of enrolment or history of myocardial infarction within the last 6 months

• Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks

• Known history of deep venous thrombosis (DVT)

• Gastrointestinal or pulmonary bleeding within the last year

• Known liver disease Aspartate transaminase (AST) or Alanine transaminase (ALT) > 3 x ULN)

• Known renal disease (serum creatinine > 1.5 x ULN)

• Use of long- term anticoagulants, antiplatelet drugs, or fibrinolytics within 7 days prior to hip replacement operation (also contraindicated during the period of prophylaxis)

• Women of childbearing potential

• Known allergy to radiopaque contrast media

• Known thrombocytopenia (prior platelet count below 100,000 cells/microliter)

• Active malignant disease

• Current H2 blocker or proton pump inhibitor treatment

• Current cytostatic treatment

• Treatment with an investigational drug in the past month

• Leg amputee

• Known alcohol or drug abuse