Trial · NCT01139658
Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
NCT01139658, Completed, Boehringer Ingelheim; results first posted 2014-01-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA. Trials, record NCT01139658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01139658
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
- NCT number
- NCT01139658
- Status
- Completed
- Enrollment
- 1,676 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Venous Thromboembolism
- First posted
- 2010-06-08
- Last updated
- 2014-01-16
- Results first posted
- 2014-01-16
- Limitations and caveats
Data for the following secondary endpoints were not collected:~Medical appointments with a general practitioner or specialist at visit 3, Frequency of medical appointments at visit 3, Prescription received at visit 3.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence of Symptomatic Venous Thromboembolic Events | 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. | participants | NUMBER |
| PRIMARY | Occurrence of Major Bleeding Events | 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. | participants | NUMBER |
| SECONDARY | Dosage of Pradaxa at Initiation | Baseline | 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. | participants | NUMBER |
| SECONDARY | Duration Between Surgery and First Dose of Pradaxa | 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. | hours | MEAN |
| SECONDARY | Duration of Treatment | 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. | days | MEAN |
| SECONDARY | Proportion of Patients With a Preoperative ALT Measurement | 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. | percentage of participants | NUMBER |
| SECONDARY | Adherence to Treatment | 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. | percent | MEAN |
| SECONDARY | Concomitant Treatments | 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. | participants | NUMBER |
| SECONDARY | Number of Patients Who Switched to Another Anticoagulant Therapy | 11 weeks | participants | NUMBER | |
| SECONDARY | Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge | 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. | participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of Symptomatic Venous Thromboembolic Events | Total Knee Replacement | 19 | participants | ||
| Occurrence of Symptomatic Venous Thromboembolic Events | Total Hip Replacement | 5 | participants | ||
| Occurrence of Major Bleeding Events | Total Knee Replacement | 8 | participants | ||
| Occurrence of Major Bleeding Events | Total Hip Replacement | 16 | participants | ||
| Dosage of Pradaxa at Initiation | Total Knee Replacement | 75 mg/day | 142 | participants | |
| Dosage of Pradaxa at Initiation | Total Hip Replacement | 75 mg/day | 162 | participants | |
| Dosage of Pradaxa at Initiation | Total Knee Replacement | 110 mg/day | 394 | participants | |
| Dosage of Pradaxa at Initiation | Total Hip Replacement | 110 mg/day | 417 | participants | |
| Dosage of Pradaxa at Initiation | Total Knee Replacement | 150 mg/day | 80 | participants | |
| Dosage of Pradaxa at Initiation | Total Hip Replacement | 150 mg/day | 122 | participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Knee Replacement | 747 | |
| Overall Study | STARTED | Total Hip Replacement | 929 | |
| Overall Study | COMPLETED | Total Knee Replacement | 691 | |
| Overall Study | COMPLETED | Total Hip Replacement | 816 | |
| Overall Study | NOT COMPLETED | Total Knee Replacement | 56 | |
| Overall Study | NOT COMPLETED | Total Hip Replacement | 113 |
Source ClinicalTrials.gov
Adverse events124
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Total Knee Replacement | 2 | 746 | |
| serious | Anaemia | Blood and lymphatic system disorders | Total Hip Replacement | 2 | 929 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Total Knee Replacement | 0 | 746 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Total Hip Replacement | 1 | 929 | |
| serious | Atrial fibrillation | Cardiac disorders | Total Knee Replacement | 4 | 746 | |
| serious | Atrial fibrillation | Cardiac disorders | Total Hip Replacement | 3 | 929 | |
| serious | Cardiac failure | Cardiac disorders | Total Knee Replacement | 1 | 746 | |
| serious | Cardiac failure | Cardiac disorders | Total Hip Replacement | 1 | 929 | |
| serious | Myocardial infarction | Cardiac disorders | Total Knee Replacement | 0 | 746 | |
| serious | Myocardial infarction | Cardiac disorders | Total Hip Replacement | 1 | 929 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Knee Replacement | ||
| Total, all-cause mortality | Total Hip Replacement | ||
| Total, other adverse events | Total Knee Replacement | 0 | 746 |
| Total, other adverse events | Total Hip Replacement | 0 | 929 |
| Total, serious adverse events | Total Knee Replacement | 48 | 746 |
| Total, serious adverse events | Total Hip Replacement | 37 | 929 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Total Knee Replacement vs Total Hip Replacement: Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge | Trial comparisons |
| Total Knee Replacement vs Total Hip Replacement: Occurrence of Major Bleeding Events | Trial comparisons |
| Total Knee Replacement vs Total Hip Replacement: Number of Patients Who Switched to Another Anticoagulant Therapy | Trial comparisons |
| Total Knee Replacement vs Total Hip Replacement: Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge | Trial comparisons |
| Total Knee Replacement vs Total Hip Replacement: Occurrence of Symptomatic Venous Thromboembolic Events | Trial comparisons |
| Total Knee Replacement vs Total Hip Replacement: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01139658
GET https://conductscience.org/api/trials/v1/NCT01139658/results?page=2