Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery

Thromboembolism Clinical Trial

Official title:

Incidence of Symptomatic Venous Thromboembolic Events and Major Bleeding Events After Dabigatran Etexilate in Patients Subject to Subject to Elective Total Hip or Knee Replacement Surgery.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00967447
• Other study ID #: 1160.103
• Status: Terminated
• Phase: N/A
• First received: August 13, 2009
• Last updated: February 24, 2014
• Start date: February 2009

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Observational

Clinical Trial Summary

Open, prospective, uncontrolled, observational cohort study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

Inclusion criteria:

• patients age 18 years or above undergoing elective total hip or knee replacement surgery

• Written informed consent obtained for data collection and source data verification.

Exclusion criteria:

According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.:

• age of > 75 years

• renal impairment (creatinine clearance <50ml/min)

• patients on concomitant therapy with amiodarone or verapamil.

• elevated liver enzymes >2 upper limit of normal (ULN) and / or hepatic impairment or liver disease expected to have any impact on survival

• anaesthesia with post-operative indwelling epidural catheters

• hypersensitivity to dabigatran etexilate or to any of the excipients

• active clinically significant bleeding

• organic lesion at risk of bleeding

• spontaneous or pharmacological impairment of haemostasis except for the above-included patients groups

• concomitant treatment with quinidine

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Thromboembolism

Locations

Country	Name	City	State
Mexico	Boehringer Ingelheim Investigational Site 1	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 10	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 11	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 12	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 13	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 14	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 15	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 16	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 17	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 18	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 19	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 2	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 20	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 3	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 4	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 5	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 6	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 7	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 8	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 9	Distrito Federal
Mexico	Boehringer Ingelheim Investigational Site 21	Guadalajara
Mexico	Boehringer Ingelheim Investigational Site 22	Guadalajara
Mexico	Boehringer Ingelheim Investigational Site 23	Guadalajara
Mexico	Boehringer Ingelheim Investigational Site 24	Guadalajara
Mexico	Boehringer Ingelheim Investigational Site 25	Guadalajara
Mexico	Boehringer Ingelheim Investigational Site 28	Monterrey
Mexico	Boehringer Ingelheim Investigational Site 26	Puebla
Mexico	Boehringer Ingelheim Investigational Site 27	Puebla

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous Thromboembolic Events		6 Months	No
Secondary	Major Bleeding Events (MBE)		From 12 To 37 Days	Yes
Secondary	Major Extra Surgical Site Bleedings		From 12 To 37 Days	Yes
Secondary	Volume of Wound Drainage		From 12 To 37 Days	No