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

Blood Loss Clinical Trial

Official title:

Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma: A Randomized Double Blind Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04494126
• Other study ID #: CMSNepal1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 15, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: August 2021
• Source: College of Medical Sciences Teaching Hospital. Nepal
• Contact: Ashutosh K Singh, MDS
• Phone: +9779855082369
• Email: dr.ashutosh[@]cmsnepel.edu.np
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days 1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients undergoing ORIF under GA for Maxillofacial fractures
• Patients between with ages of 16-65
• No cardiac comorbidities (hypertension, congenital heart malformation)
• No known coagulopathy
• No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
• ASA I and II patients

Exclusion Criteria:

• Patients younger than 16 and older than 65
• Patients with known coagulopathy
• Patients with cardiac comorbidities
• Patients with a family history of bleeding disorders
• ASA III or higher

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
College of Medical Sciences Teaching Hospital. Nepal

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications if any during surgery and upto 48 hours after surgery	complications related to surgery as reported by patient and clinician	upto 48 hours after surgery
Primary	Intraoperative blood loss	Measured and recorded from the anaesthesia patient chart	Surgical period
Secondary	Postoperative bleeding event	postoperative bleeding and ecchymosis subjectively reported by patient and assessed by clinician, recorded as a dichotomous outcome.	upto 48 hours after surgery