Comparison · NCT01940523-sae
Topical Tranexamic Acid vs Intravenous Tranexamic Acid: serious adverse 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. Topical Tranexamic Acid vs Intravenous Tranexamic Acid: serious adverse events. Trial comparisons, record NCT01940523-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01940523-sae
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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 | 0 | 0.0119 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0119 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0119 | 0.0119 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Topical Tranexamic Acid | 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. | 0 | 320 | EG000 |
| Group 2 | Intravenous Tranexamic Acid | 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure. | 0 | 320 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
- NCT number
- NCT01940523
- Phases
- PHASE4
- Conditions
- Osteoarthritis
- Interventions
- Topical Tranexamic Acid, Intravenous Tranexamic Acid
- Lead sponsor
- Hospital for Special Surgery, New York
- Results first posted
- 2017-06-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01940523?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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