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

British University In Egypt

Status and phase: Completed; Early Phase 1

Conditions: Liver Cirrhosis

Treatments: Drug: Chitosan; Drug: Ankaferd Blood Stopper; Drug: tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06457360

PED 20-2D

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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39 participants in 3 patient groups

group 1 sterile gauze with chitosan

Experimental group

Description:

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

Treatment:

Drug: Chitosan

group 2 sterile gauze with ankaferd blood stopper

Experimental group

Description:

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

Treatment:

Drug: Ankaferd Blood Stopper

group 3 sterile gauze with tranexamic acid

Active Comparator group

Description:

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

Treatment:

Drug: tranexamic acid