Trial · NCT01940523
Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
NCT01940523, Phase 4, Completed, Hospital for Special Surgery, New York; results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical. Trials, record NCT01940523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01940523
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
- NCT number
- NCT01940523
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 640 participants, actual
- Lead sponsor
- Hospital for Special Surgery, New York
- Conditions
- Osteoarthritis
- Interventions
- Topical Tranexamic Acid, Intravenous Tranexamic Acid
- First posted
- 2013-09-12
- Last updated
- 2019-11-27
- Results first posted
- 2017-06-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Blood Loss | during surgery | The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery. |
| Secondary | Drain Output | from end of surgery to 24 hours postoperatively | The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery. |
| Secondary | The Number Patients Requiring a Transfusion | over course of hospital stay (averaging three days) | TThe number Patients requiring a transfusion over the course of the patient's hospital stay. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Blood Loss | during surgery | ml | MEAN | |
| SECONDARY | Drain Output | from end of surgery to 24 hours postoperatively | ml | MEAN | |
| SECONDARY | The Number Patients Requiring a Transfusion | over course of hospital stay (averaging three days) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Blood Loss | Topical Tranexamic Acid | 323.59 | Standard Deviation 255.89 | ml | |
| Total Blood Loss | Intravenous Tranexamic Acid | 271.22 | Standard Deviation 212.06 | ml | |
| Drain Output | Topical Tranexamic Acid | 560.13 | Standard Deviation 297.21 | ml | |
| Drain Output | Intravenous Tranexamic Acid | 456.22 | Standard Deviation 275.39 | ml | |
| The Number Patients Requiring a Transfusion | IV TXA Group | 2 | Participants | ||
| The Number Patients Requiring a Transfusion | Topical TXA Group | 6 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topical Tranexamic Acid | 320 | |
| Overall Study | STARTED | Intravenous Tranexamic Acid | 320 | |
| Overall Study | COMPLETED | Topical Tranexamic Acid | 320 | |
| Overall Study | COMPLETED | Intravenous Tranexamic Acid | 320 | |
| Overall Study | NOT COMPLETED | Topical Tranexamic Acid | 0 | |
| Overall Study | NOT COMPLETED | Intravenous Tranexamic Acid | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topical Tranexamic Acid | ||
| Total, all-cause mortality | Intravenous Tranexamic Acid | ||
| Total, other adverse events | Topical Tranexamic Acid | 0 | 320 |
| Total, other adverse events | Intravenous Tranexamic Acid | 0 | 320 |
| Total, serious adverse events | Topical Tranexamic Acid | 0 | 320 |
| Total, serious adverse events | Intravenous Tranexamic Acid | 0 | 320 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IV TXA Group vs Topical TXA Group: The Number Patients Requiring a Transfusion | Trial comparisons |
| Topical Tranexamic Acid vs Intravenous Tranexamic Acid: 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/NCT01940523
GET https://conductscience.org/api/trials/v1/NCT01940523/registered