Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
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| First Received Date ICMJE | February 18, 2009 | ||||
| Last Updated Date | June 12, 2013 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety: Major bleeding events. Efficacy: composite of all death and documented symptomatic VTE (i.e documented symptomatic DVT and documented symptomatic nonfatal pulmonary embolism). [ Time Frame: up to 35 days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety: Major bleeding events. Efficacy: composite of all death and documented symptomatic VTE (i.e documented sympotomatic DVT and documented symptomatic nonfatal pulmonary embolism. [ Time Frame: up to 35 days ] | ||||
| Change History | Complete list of historical versions of study NCT00847301 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Major extra surgical site bleedings,volume of wound drainage, documented symptomatic proximal DVT, documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality [ Time Frame: up to 35 days ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Major extra surgical site bleedings,volume of wound drainage, documented symptomatic proximal DVT, documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all cause mortality [ Time Frame: up to 35 days ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery | ||||
| Official Title ICMJE | Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery | ||||
| Brief Summary | An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Moderate renal insufficiency |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Renal Impairment | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria: Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study Exclusion criteria: All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC): severe renal impairment (creatinine clearance < 30 ml/min); elevated liver enzymes > 2 upper limit of normal (ULN); 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, concomitant treatment with quinidine |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria, France, Germany, Italy, Spain, Sweden, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00847301 | ||||
| Other Study ID Numbers ICMJE | 1160.84 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Boehringer Ingelheim Pharmaceuticals | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | June 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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