Trial · NCT01139658
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of Symptomatic Venous Thromboembolic Events | 11 weeks | Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE). |
| Primary | Occurrence of Major Bleeding Events | 11 weeks | Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation. a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE). |
| Secondary | Dosage of Pradaxa at Initiation | Baseline | |
| Secondary | Duration Between Surgery and First Dose of Pradaxa | 11 weeks | |
| Secondary | Duration of Treatment | 11 weeks | |
| Secondary | Proportion of Patients With a Preoperative ALT Measurement | 11 weeks | |
| Secondary | Adherence to Treatment | 11 weeks | The adherence to treatment was measured by patient declaration. |
| Secondary | Concomitant Treatments | 11 weeks | Concomitant treatments prescribed at hospital discharge. |
| Secondary | Number of Patients Who Switched to Another Anticoagulant Therapy | 11 weeks | Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose. |
| Secondary | Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge | 11 weeks | |
| Secondary | Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge | 11 weeks | |
| Secondary | Reasons for Nurse Visits on the Day of Hospital Discharge | 11 weeks | |
| Secondary | Frequency of Nurse Visits on the Day of Hospital Discharge | 11 weeks | |
| Secondary | Duration of Unplanned Hospitalizations at Visit 3 | 11 weeks | |
| Secondary | Reasons for Unplanned Hospitalizations at Visit 3 | 11 weeks | |
| Secondary | Reasons for Usual Follow-up | 11 weeks |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01139658/registered