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

Phase 3

Completed

Conditions: Arthroplasty, Replacement, Hip
Thromboembolism

Interventions: Drug: dabigatran etexilate
Drug: enoxaparin

Registration Number: NCT00168818

Lead Sponsor: Boehringer Ingelheim

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3494

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dabigatran etexilate 75 mg	dabigatran etexilate	daily dose 150 mg once daily, half a dose on the day of surgery
dabigatran etexilate 110 mg	dabigatran etexilate	daily dose 220 mg once daily, half a dose on the day of surgery
enoxaparin	enoxaparin	40 mg once daily

Primary Outcome Measures

Name	Time	Method
Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period	First administration until 31-38 days	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.

Secondary Outcome Measures

Name	Time	Method
Death During Treatment Period	First administration until 31-38 days	All cause death, as adjudicated by the VTE events committee
Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period	First administration until 31-38 days	Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Proximal Deep Vein Thrombosis During Treatment Period	First administration until 31-38 days	Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Total Deep Vein Thrombosis During Treatment Period	First administration until 31-38 days	Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Symptomatic Deep Vein Thrombosis During Treatment Period	First administration until 31-38 days	Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Pulmonary Embolism During Treatment Period	First administration until 31-38 days	Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period	end of treatment to day 91±7	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).
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period	First administration until 31-38 days	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.
Blood Transfusion	Day 1	Blood transfusion for treated and operated patients on Day of surgery.
Volume of Blood Loss	Day 1	Volume of blood loss for treated and operated patients during surgery.
Laboratory Analyses	First administration to end of study	Frequency of patients with possible clinically significant abnormalities.

Trial Locations

Locations (116): 1160.48.06108 Canberra Hospital
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Garren, Australian Capital Territory, Australia
1160.48.06106 St George Public Hospital
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Kogarah, New South Wales, Australia
1160.48.06110 Suite 13 level 4
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Lismore, New South Wales, Australia
1160.48.06105 Flinders Medical Centre
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Bedford Park, South Australia, Australia
1160.48.06104 Ecru
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Box Hill, Victoria, Australia
1160.48.06102 Monash Medical Centre
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Clayton, Victoria, Australia
1160.48.06101 Emeritus Research
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Malvern, Victoria, Australia
1160.48.06103 Maroondah Hospital
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Ringwood East, Victoria, Australia
1160.48.06113
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Windsor, Victoria, Australia
1160.48.06111 Haemophillia & Thrombosis Service
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Perth, Western Australia, Australia
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1160.48.06108 Canberra Hospital
🇦🇺Garren, Australian Capital Territory, Australia