Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss

NCT ID: NCT06188052

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-01-31

Brief Summary

Total laryngectomy with bilateral block neck dissection is considered one of the major head and neck surgeries. Intraoperative bleeding is considered a risk factor for this operation specially that the population of this operation are elder with multiple comorbidities. Intravenous administration of tranexamic acid reduces bleeding during surgery.We design this study aiming to prove the role of topical tranexamic acid in controlling the intraoperative bleeding in patients undergoing total laryngectomy operation avoiding the risk of intravenous administration.

Detailed Description

45 patients undergoing total laryngectomy operation will be enrolled in this study. The patients will be divided into 3 equal groups, 15 patients in each group. Group (A), tranexamic acid will be given 1 hr preoperatively. Group (B), topical tranexamic acid will be given as an irrigation to the surgical site. Group (C), control group.One hour preoperatively, a wide bore cannula will be inserted to all patients. Tranexamic acid 1mg/kg will be given intravenously to patients in group (A). Normal saline will be given to Group (B) and group (C) .On arrival to the operating room, a pulse oximetry, continuous electrocardiogram (ECG), and non-invasive blood pressure measurement device will be connected to the patient. Pre-medications will be given; metoclopramide (10mg) and dexamethasone (8mg) preoperatively. Induction will be done by sevoflurane, propofol 1mg/ kg, succinyl choline 0.5mg/kg. After intubation, fentanyl 2mic/kg and atracurium 0.5mg/kg will be given , followed by 0.8 mg/kg Morphine sulphate . Anesthesia will be maintained by isoflurane 1.5% and atracurium 0.1mg/kg/ 30min. After flap elevation ( using local infiltraton of epinephrine 1/100000), the surgical site will be irrigated by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml normal saline every 1 hour for the first 5 hours in group (B), and by normal saline in group (A) and group (C).

Conditions

To Calculate Total Blood Loss Immediately Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group (A), tranexamic acid IV

tranexamic acid will be given 1 hr preoperatively as 1mg/kg intravenously

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

Comparing the 3 groups regarding intraoperative bleeding, hemoglobin level pre and postoperative and the need of blood transfusion

Group (B), topical tranexamic acid

topical tranexamic acid will be given as an irrigation by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml to the surgical site every 1 hour for the first 5 hours .

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

Comparing the 3 groups regarding intraoperative bleeding, hemoglobin level pre and postoperative and the need of blood transfusion

Group (C), control group.

Saline will be given intravenously instead of tranexamic acid And irrigation with Saline instead of tranexamic acid

Group Type: PLACEBO_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

Comparing the 3 groups regarding intraoperative bleeding, hemoglobin level pre and postoperative and the need of blood transfusion

Interventions

Tranexamic acid

Comparing the 3 groups regarding intraoperative bleeding, hemoglobin level pre and postoperative and the need of blood transfusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients of either sex, aged between 18-70 years old, ASA physical status I, II undergoing total laryngectomy

Exclusion Criteria

• Patients with coagulopathy, a history of thromboembolism or a history of tranexamic acid allergy or complication will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dina Mahmoud Mohamed

Lecturer of Anesthesia and Surgical ICU and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina M Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina M Mohamed, Lecturer

Role: CONTACT

Dinamahmoud@kasralainy.edu.eg

01005249134 ext. MD

Amr H Sayed, professor

Role: CONTACT

amr.hussein.sayed@gmail.com

01069338998 ext. MD

Facility Contacts

Dina M Mohamed, MD

Role: primary

Dinamahmoud@kasralainy.edu.eg

01005249134 ext. MD

Other Identifiers

MS-97-2023

Identifier Type: -

Identifier Source: org_study_id