Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss

NCT06188052 | Unknown Phase 4

• 1 other identifier: MS-97-2023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

To Calculate Total Blood Loss Immediately Postoperative

Outcome Measures

Primary Outcomes (1)

• To calculate total blood loss immediately postoperative and compare it in 3 groups To calculate total blood loss and compare 3 groups

  Intraoperative bleeding will be assessed and blood loss will be measured in ml ( amount of blood in canister and sponges)

  Intraoperative

Study Arms (3)

Group (A), tranexamic acid IV

ACTIVE COMPARATOR

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

Drug: Tranexamic acid

Group (B), topical tranexamic acid

ACTIVE COMPARATOR

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 .

Drug: Tranexamic acid

Group (C), control group.

PLACEBO COMPARATOR

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

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

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

Group (A), tranexamic acid IV; Group (B), topical tranexamic acid; Group (C), control group.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University hospitals

Cairo, 11559, Egypt

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Dina M Mohamed, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina M Mohamed, Lecturer

CONTACT

01005249134; Dinamahmoud@kasralainy.edu.eg

Amr H Sayed, professor

CONTACT

01069338998; amr.hussein.sayed@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All procedures will be performed by the same team, all of whom will be blind to the group assignment (except for the resident who will prepare the drug formula whether intravenous or the topical irrigation and will be responsible for randomization and drug masking using closed envelope randomization)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Surgical ICU and pain management

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: January 3, 2024
• Study Start: August 1, 2023
• Primary Completion: January 10, 2024
• Study Completion: January 31, 2024
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

EG (1)