Comparison · NCT01139658-45ea09d5
Total Knee Replacement vs Total Hip Replacement: Occurrence of Major Bleeding Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Total Knee Replacement vs Total Hip Replacement: Occurrence of Major Bleeding Events. Trial comparisons, record NCT01139658-45ea09d5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01139658-45ea09d5
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0107 | 0.00544 | 0.021 | wilson | |
| Risk in group 2 | 0.0172 | 0.0106 | 0.0278 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0065 | -0.0183 | 0.00573 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.623 | 0.268 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 0.619 | 0.263 | 1.45 | log | |
| Number needed to treat, for one fewer participant with the outcome on Total Knee Replacement than on Total Hip Replacement | 154 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Total Knee Replacement | Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting. | 8 | 746 | OG000 |
| Group 2 | Total Hip Replacement | Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting. | 16 | 929 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Occurrence of Major Bleeding Events
- Description
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).
- Time frame
- 11 weeks
- Population
- 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.
Source ClinicalTrials.gov
Trial
- Title
- Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
- NCT number
- NCT01139658
- Phases
- Conditions
- Venous Thromboembolism
- Interventions
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2014-01-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01139658?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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