Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

Boehringer Ingelheim3,494 enrolled

Overview

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

3,494

Conditions

Thromboembolism Arthroplasty, Replacement, Hip

Interventions

dabigatran etexilateDRUG

daily dose 150 mg once daily, half a dose on the day of surgery

dabigatran etexilateDRUG

daily dose 150 mg once daily, half a dose on the day of surgery

enoxaparinDRUG

40 mg once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria Inclusion criteria (selected): * Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement * Written Informed Consent Exclusion criteria Exclusion criteria (selected): * Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia. * Active malignant disease or current cytostatic treatment * Known severe renal insufficiency * Liver disease expected to have any potential impact on survival, or elevated AST or ALT \> 2x upper limit of normal * Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months * Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control * Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran * Contraindications to enoxaparin * Participation in a clinical trial during the last 30 days

Locations (116)

Outcomes

Primary Outcomes

Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.

Time frame: First administration until 31-38 days

Secondary Outcomes

Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period

Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee

Time frame: First administration until 31-38 days

Proximal Deep Vein Thrombosis During Treatment Period

Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee

Time frame: First administration until 31-38 days

Total Deep Vein Thrombosis During Treatment Period

Total Deep Vein Thrombosis as adjudicated by the VTE events committee

Time frame: First administration until 31-38 days

Symptomatic Deep Vein Thrombosis During Treatment Period

Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee

Time frame: First administration until 31-38 days

Pulmonary Embolism During Treatment Period

Data from ClinicalTrials.gov

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1160.48.06108 Canberra Hospital

Garren, Australian Capital Territory, Australia

1160.48.06106 St George Public Hospital

Kogarah, New South Wales, Australia

1160.48.06110 Suite 13 level 4

Lismore, New South Wales, Australia

1160.48.06105 Flinders Medical Centre

Bedford Park, South Australia, Australia

1160.48.06104 Ecru

Box Hill, Victoria, Australia

1160.48.06102 Monash Medical Centre

Clayton, Victoria, Australia

1160.48.06101 Emeritus Research

Malvern, Victoria, Australia

1160.48.06103 Maroondah Hospital

Ringwood East, Victoria, Australia

1160.48.06113

Windsor, Victoria, Australia

1160.48.06111 Haemophillia & Thrombosis Service

Perth, Western Australia, Australia

...and 106 more locations

Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

Major bleeding events were defined as * fatal * clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected * clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected * symptomatic retroperitoneal, intracranial, intraocular or intraspinal * requiring treatment cessation * leading to re-operation Clinically-relevant was defined as * spontaneous skin hematoma greater than or equal to 25 cm² * wound hematoma greater than or equal to 100 cm² * spontaneous nose bleed lasting longer than 5 min * macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention * spontaneous rectal bleeding (more than a spot on toilet paper) * gingival bleeding lasting longer than 5 min * any other bleeding event considered clinically relevant by the investigator Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.

Time frame: First administration until 31-38 days