Trial · NCT02043132
Tranexamic Acid in Reverse Total Shoulder Arthroplasty
NCT02043132, Phase 2, Phase 3, Completed, Corewell Health East; results first posted 2017-06-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tranexamic Acid in Reverse Total Shoulder Arthroplasty. Trials, record NCT02043132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02043132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tranexamic Acid in Reverse Total Shoulder Arthroplasty
- NCT number
- NCT02043132
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 116 participants, actual
- Lead sponsor
- Corewell Health East
- Conditions
- Shoulder Joint Disease, Complications; Arthroplasty, Intraoperative Complications, Blood Loss, Surgical
- Interventions
- Tranexamic Acid, Placebo
- First posted
- 2014-01-23
- Last updated
- 2017-06-19
- Results first posted
- 2017-06-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Blood Loss | Preoperative through Postoperative Days 1 and 2 | Total Blood Loss as calculated according to method as described by Good et al. Total Blood Loss (mL) = 1000 X Hb(loss)/Hb(initial) |
| Primary | Total Hemoglobin Loss | Preoperative through Postoperative Days 1 and 2 | Total hemoglobin loss estimated using the formula for total blood volume described by Nadler et al Hb(loss) = blood volume (L) x \[Hb(initial)(g/L) - Hb(final)(g/L)\] + Hb(transfused) |
| Primary | Total Drain Output | 0-48 hours postoperatively | Total Drain Output as measured postoperatively 0-48 hours |
| Secondary | Number of Participants Experiencing Pulmonary Embolism | up to 6-weeks post-operatively | The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Pulmonary Embolism |
| Secondary | Number of Participants Experiencing Myocardial Infarction | up to 6-weeks post-operatively | The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Myocardial infarction |
| Secondary | Number of Participants Experiencing Deep Vein Thrombosis | up to 6-weeks post-operatively | The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Deep venous thrombosis |
| Secondary | Number of Participants Experiencing Hematoma as a Surgical Site Complication | up to 6-weeks post-operatively | The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Hematoma |
| Secondary | Number of Participants Experiencing Infection as a Surgical Site Complication | up to 6-weeks post-operatively | The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Infection |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Blood Loss | Preoperative through Postoperative Days 1 and 2 | Total Blood Loss (mL) | MEAN | |
| PRIMARY | Total Hemoglobin Loss | Preoperative through Postoperative Days 1 and 2 | g | MEAN | |
| PRIMARY | Total Drain Output | 0-48 hours postoperatively | mL | MEAN | |
| SECONDARY | Number of Participants Experiencing Pulmonary Embolism | up to 6-weeks post-operatively | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Myocardial Infarction | up to 6-weeks post-operatively | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Deep Vein Thrombosis | up to 6-weeks post-operatively | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Hematoma as a Surgical Site Complication | up to 6-weeks post-operatively | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Infection as a Surgical Site Complication | up to 6-weeks post-operatively | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Blood Loss | Tranexamic Acid | 1122.4 | Standard Deviation 411.6 | Total Blood Loss (mL) | |
| Total Blood Loss | Normal Saline | 1472 | Standard Deviation 475.4 | Total Blood Loss (mL) | |
| Total Hemoglobin Loss | Tranexamic Acid | 154.6 | 95% Confidence Interval 138.0 to 171.2 | g | |
| Total Hemoglobin Loss | Normal Saline | 200.1 | 95% Confidence Interval 181.3 to 218.8 | g | |
| Total Drain Output | Tranexamic Acid | 221 | 95% Confidence Interval 186 to 256 | mL | |
| Total Drain Output | Normal Saline | 372 | 95% Confidence Interval 324 to 420 | mL | |
| Number of Participants Experiencing Pulmonary Embolism | Tranexamic Acid | 0 | Participants | ||
| Number of Participants Experiencing Pulmonary Embolism | Normal Saline | 0 | Participants | ||
| Number of Participants Experiencing Myocardial Infarction | Tranexamic Acid | 0 | Participants | ||
| Number of Participants Experiencing Myocardial Infarction | Normal Saline | 1 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tranexamic Acid | 58 | |
| Overall Study | STARTED | Normal Saline | 58 | |
| Overall Study | COMPLETED | Tranexamic Acid | 53 | |
| Overall Study | COMPLETED | Normal Saline | 49 | |
| Overall Study | NOT COMPLETED | Tranexamic Acid | 5 | |
| Overall Study | NOT COMPLETED | Normal Saline | 9 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| other | Skin Allergic Reaction | Skin and subcutaneous tissue disorders | Tranexamic Acid | 0 | 53 | 0 |
| other | Skin Allergic Reaction | Skin and subcutaneous tissue disorders | Normal Saline | 1 | 49 | 1 |
| other | Syncopal fall | General disorders | Tranexamic Acid | 1 | 53 | 1 |
| other | Syncopal fall | General disorders | Normal Saline | 0 | 49 | 0 |
| serious | Non-ST elevation myocardial infarction | Cardiac disorders | Tranexamic Acid | 0 | 53 | 0 |
| serious | Non-ST elevation myocardial infarction | Cardiac disorders | Normal Saline | 1 | 49 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tranexamic Acid | 0 | 53 |
| Total, all-cause mortality | Normal Saline | 0 | 49 |
| Total, other adverse events | Tranexamic Acid | 1 | 53 |
| Total, other adverse events | Normal Saline | 1 | 49 |
| Total, serious adverse events | Tranexamic Acid | 0 | 53 |
| Total, serious adverse events | Normal Saline | 1 | 49 |
Source ClinicalTrials.gov
Papers40
The papers the trial lists on ClinicalTrials.gov.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tranexamic Acid vs Normal Saline: Number of Participants Experiencing Deep Vein Thrombosis | Trial comparisons |
| Tranexamic Acid vs Normal Saline: Number of Participants Experiencing Myocardial Infarction | Trial comparisons |
| Tranexamic Acid vs Normal Saline: Number of Participants Experiencing Pulmonary Embolism | Trial comparisons |
| Tranexamic Acid vs Normal Saline: Number of Participants Experiencing Infection as a Surgical Site Complication | Trial comparisons |
| Tranexamic Acid vs Normal Saline: Number of Participants Experiencing Hematoma as a Surgical Site Complication | Trial comparisons |
| Tranexamic Acid vs Normal Saline: deaths from any cause | Trial comparisons |
| Tranexamic Acid vs Normal Saline: 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/NCT02043132
GET https://conductscience.org/api/trials/v1/NCT02043132/papers?page=2