Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery

Terminated

• Conditions: Venous Thromboembolism; Arthroplasty, Replacement
• Interventions: Drug: dabigatran

• Registration Number: NCT01153698
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

an open, prospective, observational study to collect data on safety (major bleeding events) and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement (THR)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Study Start: 2010-08
• Primary Completion: 2011-12-21
• Study Completion: 2011-12-21
• Results First Submitted: 2012-11-30
• Results First Submitted QC: 2012-11-30
• Results First Posted: 2013-01-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients after hip or knee replacement	dabigatran	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period	From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)	Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs were: 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.
Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period	From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)	sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period	From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed	sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.
Percentage of Patients With MBE During Total Treatment Period	From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed	MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: 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.
Percentage of Patients With MBE During Pre-switch Treatment Period	From first enoxaparin administration until last enoxaparin administration	MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: 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.
Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period	From first enoxaparin administration until last enoxaparin administration	sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.
Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period	From last enoxaparin administration until first Pradaxa intake	sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.; Symptomatic DVT is defined as clinically symptomatic venous thromboembolic event and symptomatic non-fatal PE is defined as symptomatic pulmonary embolism
Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period	From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed	Major extra-surgical site bleedings include all major bleedings not occurred at surgical site
Volume of Wound Drainage (Post-operative)	From end of surgery (before first dosing) until 24 hours after last Pradaxa intake	Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.
Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period	From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)	Total treatment period is defined from first enoxaparin administration to 24h after last Pradaxa intake or to 35h after last enoxaparin administration if no switch was performed.

Trial Locations

Locations (7)

1160.118.43007 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1160.118.43004 Boehringer Ingelheim Investigational Site; 🇦🇹 Braunau, Austria

1160.118.43016 Boehringer Ingelheim Investigational Site; 🇦🇹 Stolzalpe, Austria

1160.118.43002 Boehringer Ingelheim Investigational Site; 🇦🇹 Ehebichl, Austria

1160.118.43011 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1160.118.43005 Boehringer Ingelheim Investigational Site; 🇦🇹 Graz, Austria

1160.118.43001 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria