Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-30

Brief Summary

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Tranexamic acid in debridement surgery of burns on the volume of bleeding in transfusion requirements

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Detailed Description

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A randomized, double-blind, prospective trial was conducted to establish the effect of intraoperative tranexamic acid in the early surgical debridement of severe burns. The study was carried out between the months of January 2022 and December 2023.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Randomized, double-blind, prospective trial to establish the effect of intraoperative tranexamic acid in early surgical debridement of severe burns. The study was carried out between the months of January 2022 to December 2022.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tranexamic acid

A total of 20 patients were included: 9 patients in the tranexamic acid group

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

10mg/kg intravenous single dose

placebo

A total of 20 patients were included: 11 patients in the control group using 0.9% isotonic saline solution.

Group Type PLACEBO_COMPARATOR

0.9% isotonic saline solution

Intervention Type OTHER

100 ml intravenous single dose

Interventions

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Tranexamic acid

10mg/kg intravenous single dose

Intervention Type DRUG

0.9% isotonic saline solution

100 ml intravenous single dose

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. First-time patients undergo surgical debridement of their burns.
2. A burn percentage of 10-30% of burned body surface area
3. Patients over 18 years of age
4. Patients under 40
5. IMSS beneficiaries

Exclusion Criteria

1. Burned patients with previous surgical debridement.
2. Patients with co-morbids.
3. Patients with a history of drug hypersensitivity.
4. Patients with kidney disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No