Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss

Kasr El Aini Hospital

Status and phase: Enrolling; Phase 4

Conditions: To Calculate Total Blood Loss Immediately Postoperative

Treatments: Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06188052

MS-97-2023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

Group (A), tranexamic acid IV

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic acid

Group (B), topical tranexamic acid

Active Comparator group

Description:

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 .

Treatment:

Drug: Tranexamic acid

Group (C), control group.

Placebo Comparator group

Description:

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

Treatment:

Drug: Tranexamic acid