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

NCT06301204 | Completed

• 1 other identifier: 21.06.2022-E.67046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tranexamic Acid; Orthognathic Surgery; Edema; Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• postoperative edema calculation for the first 1-3 and 7 day (cm)

  post operative 1-3-7 days

• intraoperative surgical site evaluation (Fromme Scale)

  during the surgical time (hour)

• Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day

  during the preoperative and post operative 2. day

Study Arms (3)

control group

PLACEBO COMPARATOR

control group patient give no drug administration during bimaxillary orthognathic surgery.

Drug: Saline

group 1(intravenous administration of 250 mg tranexamic acid)

ACTIVE COMPARATOR

group 1 (TRANEXEL 250 mg/5 mL) patients administered 250 mg tnx acid during the whole bimaxillary orthognathic surgery

Drug: Tranexamic acid injection

group 2 (intravenous administration of 500 mg tranexamic acid)

ACTIVE COMPARATOR

group 2 (TRANEXEL 250 mg/5 mL) patients administered 500 mg tnx acid during the whole surgery.

Drug: Tranexamic acid injection

Interventions

Tranexamic acid injection DRUG

tranexamic acid administration 250mg or 500 mg

group 1(intravenous administration of 250 mg tranexamic acid); group 2 (intravenous administration of 500 mg tranexamic acid)

Saline DRUG

onyl ıv saline (NaCl 0.09%)

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf Universty

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Edema; Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)