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Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma

NCT04494126 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-08-03

No results posted yet for this study

Summary

This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are objectively rated and complications are noted.

Conditions

  • Blood Loss

Interventions

DRUG

Tranexamic acid

Drug: Tranexamic Acid Injectable Solution the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia before incision.

DRUG

Placebo

Other: Placebo (normal saline 0.9%) An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.

Sponsors & Collaborators

  • College of Medical Sciences Teaching Hospital. Nepal

    lead OTHER

Principal Investigators

  • Rajesh Yadav, MD · College of Medical Sciences Teaching hospital, Bharatpur, Nepal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-15
Primary Completion
2021-10-15
Completion
2021-12-15

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Drugs

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 NCT04494126 on ClinicalTrials.gov