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NCT05705336

Clinical Trial Analyzing the Efficacy of Oral Administration of Tranexamic Acid in Spine Surgery.

Completed Phase 4 Last updated 30 January 2023
What this trial tests

Phase 4 trial testing Tranexamic Acid Oral Product in Tranexamic Acid (TXA) in 60 participants. Completed in 1 January 2022.

Timeline
1 January 2021
Primary endpoint
30 December 2021
1 January 2022

Quick facts

Lead sponsorAlejandro Reyes Sánchez
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment60
Start date1 January 2021
Primary completion30 December 2021
Estimated completion1 January 2022
Sites1 location across Mexico

Drugs / interventions tested

Conditions studied

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.

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Trials testing the same drug.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing