Trial · NCT04089865
Oral Versus Intravenous Tranexamic Acid
NCT04089865, Phase 4, Completed, Hospital for Special Surgery, New York; results first posted 2023-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Versus Intravenous Tranexamic Acid. Trials, record NCT04089865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04089865
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Versus Intravenous Tranexamic Acid
- NCT number
- NCT04089865
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 400 participants, actual
- Lead sponsor
- Hospital for Special Surgery, New York
- Conditions
- Blood Loss, Blood Transfusion
- Interventions
- Tranexamic Acid
- First posted
- 2019-09-13
- Last updated
- 2024-12-27
- Results first posted
- 2023-06-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Calculated Blood Loss | post-operative day 0 | Calculated Blood loss (CBL) measured in mL, measured at baseline (before surgery) and in the post-operative care unit (after surgery). The following formula was used CBL = BV × (HctPre - HctPost), where BV = (k1 × H3) + (k2 × W) + k3. The variables for the formula are as followed: CBL: Calculated blood loss BV: Blood volume at baseline HctPre: Haematocrit before surgery HctPost: Haematocrit after surgery H: Patient height in meters W: Patient weight in kilograms Although measured at two time points (before and after surgery), the calculated value from those two time points is average across all participants and reported. |
| Secondary | Transfusion During Hospital Stay | From Post-Operative Day 0 to Post-Operative Day 2 | To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no). |
| Secondary | Time to Discharge From Physical Therapy | From 48-72 hours after surgery | Time to discharge from physical therapy (in minutes) |
| Secondary | Length of Stay | After surgery to the time discharged from hospital (estimated 48-72 hours after surgery) | Hospital length of stay (in minutes) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Calculated Blood Loss | post-operative day 0 | CBL (ml) | MEAN | |
| SECONDARY | Transfusion During Hospital Stay | From Post-Operative Day 0 to Post-Operative Day 2 | participants | NUMBER | |
| SECONDARY | Time to Discharge From Physical Therapy | From 48-72 hours after surgery | minutes | MEAN | |
| SECONDARY | Length of Stay | After surgery to the time discharged from hospital (estimated 48-72 hours after surgery) | minutes | MEAN |
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 |
|---|---|---|---|---|---|
| Calculated Blood Loss | Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | 842 | Standard Deviation 328 | CBL (ml) | |
| Calculated Blood Loss | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 860 | Standard Deviation 313 | CBL (ml) | |
| Calculated Blood Loss | Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | 799 | Standard Deviation 334 | CBL (ml) | |
| Calculated Blood Loss | Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | 878 | Standard Deviation 348 | CBL (ml) | |
| Transfusion During Hospital Stay | Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | 0 | participants | ||
| Transfusion During Hospital Stay | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 0 | participants | ||
| Transfusion During Hospital Stay | Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | 0 | participants | ||
| Transfusion During Hospital Stay | Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | 1 | participants | ||
| Time to Discharge From Physical Therapy | Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | 2091.33 | Standard Deviation 1203.17 | minutes | |
| Time to Discharge From Physical Therapy | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 1914.45 | Standard Deviation 1055.47 | minutes |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Hip Arthroplasty - Oral TXA | 100 | |
| Overall Study | STARTED | Total Hip Arthroplasty - Intravenous TXA | 100 | |
| Overall Study | STARTED | Total Knee Arthroplasty - Oral TXA | 100 | |
| Overall Study | STARTED | Total Knee Arthroplasty - Intravenous TXA | 100 | |
| Overall Study | COMPLETED | Total Hip Arthroplasty - Oral TXA | 98 | |
| Overall Study | COMPLETED | Total Hip Arthroplasty - Intravenous TXA | 98 | |
| Overall Study | COMPLETED | Total Knee Arthroplasty - Oral TXA | 93 | |
| Overall Study | COMPLETED | Total Knee Arthroplasty - Intravenous TXA | 98 | |
| Overall Study | NOT COMPLETED | Total Hip Arthroplasty - Oral TXA | 2 | |
| Overall Study | NOT COMPLETED | Total Hip Arthroplasty - Intravenous TXA | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events8
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 | Complications | Blood and lymphatic system disorders | Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | 5 | 89 | |
| other | Complications | Blood and lymphatic system disorders | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 2 | 90 | |
| other | Complications | Blood and lymphatic system disorders | Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | 0 | 90 | |
| other | Complications | Blood and lymphatic system disorders | Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | 2 | 96 | |
| serious | CVA, cerebrovascular accident | Vascular disorders | Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | 0 | 89 | |
| serious | CVA, cerebrovascular accident | Vascular disorders | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 1 | 90 | |
| serious | CVA, cerebrovascular accident | Vascular disorders | Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | 0 | 90 | |
| serious | CVA, cerebrovascular accident | Vascular disorders | Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | 0 | 96 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | 0 | 89 |
| Total, all-cause mortality | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 0 | 90 |
| Total, all-cause mortality | Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | 0 | 90 |
| Total, all-cause mortality | Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | 0 | 96 |
| Total, other adverse events | Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | 5 | 89 |
| Total, other adverse events | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 2 | 90 |
| Total, other adverse events | Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | 0 | 90 |
| Total, other adverse events | Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | 2 | 96 |
| Total, serious adverse events | Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | 0 | 89 |
| Total, serious adverse events | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 1 | 90 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04089865
GET https://conductscience.org/api/trials/v1/NCT04089865/registered