Last reviewed · How we verify
NCT05705336
Clinical Trial Analyzing the Efficacy of Oral Administration of Tranexamic Acid in Spine Surgery.
Phase 4 trial testing Tranexamic Acid Oral Product in Tranexamic Acid (TXA) in 60 participants. Completed in 1 January 2022.
30 December 2021
Quick facts
| Lead sponsor | Alejandro Reyes Sánchez |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 January 2021 |
| Primary completion | 30 December 2021 |
| Estimated completion | 1 January 2022 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Tranexamic Acid Oral Product — full drug profile →
- Placebo pills — full drug profile →
Conditions studied
- Tranexamic Acid (TXA) — all drugs for Tranexamic Acid (TXA) →
- Prospective Study — all drugs for Prospective Study →
- Evidence-based Medicine — all drugs for Evidence-based Medicine →
- Randomized Controlled Trial — all drugs for Randomized Controlled Trial →
Sponsor
Alejandro Reyes Sánchez — full company profile →
Who can join
Adults 40 to 70, any sex, with Tranexamic Acid (TXA) or Prospective Study. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study design: Randomized control trial Purpose: Evaluate the efficacy of oral administration of tranexamic acid (TXA) in spine surgeries to achieve blood loss reduction. Methods. A total of 60 patients undergoing major surgery of the spine, were randomly assigned into 2 groups. Group 1 was assigned as the control group and the other one included oral administration of tranexamic acid 2 hours prior to surgery. Outcomes measures included intraoperative blood loss, postoperative blood loss, hematological parameters, blood transfusion needed, and surgical complications.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05705336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tranexamic Acid Oral Product
Trials testing the same drug.
- NCT04691362 — Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty · Phase 4 · completed
- NCT03751163 — Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05705336 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alejandro Reyes Sánchez
- Last refreshed: 30 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05705336.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing