Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding, Edema And Physician Comfort In Orthognathıc Surgery Patients

Evaluation Of The Effectiveness Of Tranexamic Acid Application Protocol With Different Doses On Bleeding, Edema And Physician Comfort In Bimaxillary Orthognathic Surgery Patients

The aim of this clinical study conducted in accordance with the information in the literature is to compare the effects of administering tranexamic acid during orthognathic surgery, at different doses. Specifically, investigators aim to compare the effects of administering 1 ampoule IV (approximately 3 mg/kg) and 2 ampoules IV (approximately 6 mg/kg), and evaluate their impact on intraoperative bleeding (ml), surgical duration (min), postoperative swelling, and intraoperative surgical field evaluation (Fromme Scale), by comparing them with control group (applying no drug administration) patient data.

Study Overview

• Status: Completed
• Conditions: Edema; Bleeding; Orthognathic Surgery; Tranexamic Acid
• Intervention / Treatment: Drug: Saline; Drug: Tranexamic acid injection

Detailed Description

This prospective double blind clinical study was approved by the Bezmialem Vakif University Clinical Research Ethics Committee (2022-E.6706). All patients were provided detailed explanations of the surgical procedure and potential adverse events, underwent preoperative anesthesia assessments, and provided informed consent. A total of 60 patients were included in the study and were randomly assigned to three groups: Study Group 1 (N=20), Study Group 2 (N=20), and Control Group (N=20). In Study Group 1, patients received local anesthesia prior to bimaxillary osteotomy, followed by intravenous administration of 250 mg / 2.5 mL tranexamic acid before starting with the incision. In Study Group 2, patients also received local anesthesia before bimaxillary osteotomy, followed by intravenous administration of 250 mg / 2.5 mL tranexamic acid for le fort 1 and, a second dose of 250 mg / 2.5 mL tranexamic acid was administered for beginning of the sagittal split osteotomy. The Control Group, Group 3, did not receive any medication before or after surgery. All patients underwent bimaxillary surgery using the same surgical technique and same surgical team.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Bezmialem Vakıf Universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with class 2 or class 3 dentofacial malformation who are planned to undergo bimaxillary orthognathic surgery.
2. Patients who have not had orthognathic surgery before
3. Patients without cleft lip and palate
4. Patients without systemic bleeding diets

Exclusion Criteria:

1. Having a systemic disease that affects general health status
2. Presence of a malignant disease in the head and neck region
3. Patients who have previously undergone orthognathic surgery
4. Patients with any bleeding disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; control group patient give no drug administration during bimaxillary orthognathic surgery.	Drug: Saline; onyl ıv saline (NaCl 0.09%)
Active Comparator: group 1(intravenous administration of 250 mg tranexamic acid); group 1 (TRANEXEL 250 mg/5 mL) patients administered 250 mg tnx acid during the whole bimaxillary orthognathic surgery	Drug: Tranexamic acid injection; tranexamic acid administration 250mg or 500 mg
Active Comparator: group 2 (intravenous administration of 500 mg tranexamic acid); group 2 (TRANEXEL 250 mg/5 mL) patients administered 500 mg tnx acid during the whole surgery.	Drug: Tranexamic acid injection; tranexamic acid administration 250mg or 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative bleeding during the surgery (ml)	the primary outcome is this study is assessment of the intraoperative bleeding: Intraoperative bleeding will be calculated by subtracting the total amount of iv fluid and the amount of irrigation solutions used during surgery from the total amount of aspirate volume.	during the operation time (hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative edema calculation for the first 1-3 and 7 day (cm)	the first secondary outcome of this study is post operative edema: Prior to anesthesia induction, Tragus (Tra) and Gonion (Go) points were marked with methylene blue, and distances including Lateral Canthus - Gonion, Tragus-Commissure, and interincisal distances were measured with a paper ruler and recorded as preoperative measurements.Measurements of Lateral Canthus - Gonion, Tragus-Commissure, and Interincisal distances were repeated on postoperative days 1, 3, and 7 for evaluating postoperative edema.	post operative 1-3-7 days
intraoperative surgical site evaluation (Fromme Scale)	the second secondary outcome is surgical site evaluation during the surgery. Surgeon evaluate the surgical site according to Fromme Scale per every one hour. 0 = No bleeding, virtually bloodless field; = Bleeding so mild it is not even a surgical nuisance; = Moderate bleeding, a nuisance but without interference with accurate dissection; = Moderate bleeding that moderately compromises surgical dissection; = Heavy but controllable that significantly interferes with dissection; = Massive uncontrollable bleeding	during the surgical time (hour)
Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day	Hemoglobin (Hgb) and Hematocrit (Hct) values were recorded preoperatively and second postoperative day.	during the preoperative and post operative 2. day

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Edema; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 21.06.2022-E.67046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No