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

Primary Purpose

Blood Loss

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Tranexamic acid

Placebo

About this trial

This is an interventional prevention trial for Blood Loss focused on measuring Maxillofacial trauma; blood loss

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic acid

Placebo

Arm Description

Experimental: TXA Group One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.

Placebo Comparator: Control Group Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.

Outcomes

Primary Outcome Measures

Intraoperative blood loss

Measured and recorded from the anaesthesia patient chart

Secondary Outcome Measures

Postoperative bleeding event

postoperative bleeding and ecchymosis subjectively reported by patient and assessed by clinician, recorded as a dichotomous outcome.

Full Information

NCT ID

NCT04494126

First Posted

July 28, 2020

Last Updated

August 1, 2021

Sponsor

College of Medical Sciences Teaching Hospital. Nepal

1. Study Identification

Unique Protocol Identification Number

NCT04494126

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 15, 2021 (Anticipated)

Primary Completion Date

October 15, 2021 (Anticipated)

Study Completion Date

December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

College of Medical Sciences Teaching Hospital. Nepal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Loss

Keywords

Maxillofacial trauma; blood loss

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double-blind, Parallel assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Only the anaesthesiologist who is administering the medications is unmasked until completion of the data collection period.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic acid

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Comparator: Control Group Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.

Intervention Type

Drug

Intervention Name(s)

Tranexamic acid

Other Intervention Name(s)

Injection TXA 1 gram

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal saline

Intervention Description

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.

Primary Outcome Measure Information:

Title

Intraoperative blood loss

Description

Measured and recorded from the anaesthesia patient chart

Time Frame

Surgical period

Secondary Outcome Measure Information:

Title

Postoperative bleeding event

Description

postoperative bleeding and ecchymosis subjectively reported by patient and assessed by clinician, recorded as a dichotomous outcome.

Time Frame

upto 48 hours after surgery

Other Pre-specified Outcome Measures:

Title

Complications if any during surgery and upto 48 hours after surgery

Description

complications related to surgery as reported by patient and clinician

Time Frame

upto 48 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ashutosh K Singh, MDS

Phone

+9779855082369

dr.ashutosh@cmsnepel.edu.np

First Name & Middle Initial & Last Name or Official Title & Degree

Ashutosh K Singh, MDS

Phone

+9779804244369

drashutoshkumarsingh@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rajesh Yadav, MD

Organizational Affiliation

College of Medical Sciences Teaching hospital, Bharatpur, Nepal

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The data will be used for internal use only. Any patient identifier will be removed from the final master chart before statistical analysis.

Learn more about this trial

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

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