Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children

NCT06457360 | Completed Early Phase 1 DMC

• 1 other identifier: PED 20-2D
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is: To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases where the: • Primary objective: is to evaluate which of the previous materials will be the most effective as a hemostatic agent

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases

  evaluation of the previous materials which will be the most effective as a hemostatic agent by measuring blood loss after dental extraction after 30 minutes by the weight difference between the gauze preoperatively and postoperatively using fine electronic measurement weight device

  30 minutes

Secondary Outcomes (1)

• pain score assessment

  7 days

Study Arms (3)

group 1 sterile gauze with chitosan

EXPERIMENTAL

Chitosan-based dressing gauze after extraction in patients with end stage liver disease

Drug: Chitosan

group 2 sterile gauze with ankaferd blood stopper

EXPERIMENTAL

ankaferd blood stopper dressing gauze after extraction in patients with end stage liver disease

Drug: Ankaferd Blood Stopper

group 3 sterile gauze with tranexamic acid

ACTIVE COMPARATOR

tranexamic acid dressing gauze after extraction in patients with end stage liver disease

Drug: tranexamic acid

Interventions

tranexamic acid DRUG

Application of sterile gauze after extraction for hemostasis

group 3 sterile gauze with tranexamic acid

Ankaferd Blood Stopper DRUG

Application of sterile gauze after extraction for hemostasis

group 2 sterile gauze with ankaferd blood stopper

Chitosan DRUG

Application of sterile gauze after extraction for hemostasis

group 1 sterile gauze with chitosan

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with end stage liver disease that need dental extraction before liver transplant
• Patients aged between 4 and 9 years old
• Patients having international normalized ratio (INR) values ≤ 4 (i.e. 1-4)

You may not qualify if:

• Patients with allergy to sea food because chitosan- based dressing is manufactured from freeze-dried chitosan, derived from shrimp shell.
• Patients having genetic bleeding disorders
• Patients with renal diseases

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

British University in Egypt

Cairo, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Tranexamic Acid; ankaferd blood stopper; Chitosan

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Officials

• noha S Kabil

  British University In Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: June 13, 2024
• Study Start: November 15, 2023
• Primary Completion: January 20, 2024
• Study Completion: May 20, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

EG (1)