Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss

Phase 4

Recruiting

• Conditions: To Calculate Total Blood Loss Immediately Postoperative
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT06188052
• Lead Sponsor: Kasr El Aini Hospital

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).

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-09-19
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (A), tranexamic acid IV	Tranexamic acid	tranexamic acid will be given 1 hr preoperatively as 1mg/kg intravenously
Group (B), topical tranexamic acid	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 (C), control group.	Tranexamic acid	Saline will be given intravenously instead of tranexamic acid And irrigation with Saline instead of tranexamic acid

Primary Outcome Measures

Name	Time	Method
To calculate total blood loss immediately postoperative and compare it in 3 groups To calculate total blood loss and compare 3 groups	Intraoperative	Intraoperative bleeding will be assessed and blood loss will be measured in ml ( amount of blood in canister and sponges)

Trial Locations

Locations (1)

Cairo University hospitals; 🇪🇬 Cairo, Egypt