Comparison · NCT02043132-sae
Tranexamic Acid vs Normal Saline: 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. Tranexamic Acid vs Normal Saline: serious adverse events. Trial comparisons, record NCT02043132-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02043132-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 | 0.0676 | wilson | |
| Risk in group 2 | 0.0204 | 0.00361 | 0.107 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0204 | -0.107 | 0.0492 | 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 treat, for one fewer participant with a serious adverse event on Tranexamic Acid than on Normal Saline | 49 | 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 | Tranexamic Acid | Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution. | 0 | 53 | EG000 |
| Group 2 | Normal Saline | Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.~Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution. | 1 | 49 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Tranexamic Acid in Reverse Total Shoulder Arthroplasty
- NCT number
- NCT02043132
- Phases
- PHASE2, PHASE3
- Conditions
- Shoulder Joint Disease, Complications; Arthroplasty, Intraoperative Complications, Blood Loss, Surgical
- Interventions
- Tranexamic Acid, Placebo
- Lead sponsor
- Corewell Health East
- Results first posted
- 2017-06-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02043132?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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