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

NCT05705336 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-30

No results posted yet for this study

Summary

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.

Conditions

  • Tranexamic Acid (TXA)
  • Prospective Study
  • Evidence-based Medicine
  • Randomized Controlled Trial

Interventions

DRUG

Tranexamic Acid Oral Product

Single dose of 1950 mg (3 tablets of 650 mg) was administered orally 2 hours before the surgical incision.

DRUG

Placebo pills

Single dose of 3 standard placebo pills administered orally 2 hours before the surgical incision.

Sponsors & Collaborators

  • Alejandro Reyes Sánchez

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-30
Completion
2022-01-01
FDA Drug
Yes

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705336 on ClinicalTrials.gov