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

NCT ID: NCT06457360

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2024-05-20

Brief Summary

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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

Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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group 1 sterile gauze with chitosan

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

Group Type EXPERIMENTAL

Chitosan

Intervention Type DRUG

Application of sterile gauze after extraction for hemostasis

group 2 sterile gauze with ankaferd blood stopper

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

Group Type EXPERIMENTAL

Ankaferd Blood Stopper

Intervention Type DRUG

Application of sterile gauze after extraction for hemostasis

group 3 sterile gauze with tranexamic acid

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

Group Type ACTIVE_COMPARATOR

tranexamic acid

Intervention Type DRUG

Application of sterile gauze after extraction for hemostasis

Interventions

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tranexamic acid

Application of sterile gauze after extraction for hemostasis

Intervention Type DRUG

Ankaferd Blood Stopper

Application of sterile gauze after extraction for hemostasis

Intervention Type DRUG

Chitosan

Application of sterile gauze after extraction for hemostasis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British University In Egypt

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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noha S Kabil

Role: PRINCIPAL_INVESTIGATOR

British University In Egypt

Locations

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British University in Egypt

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PED 20-2D

Identifier Type: -

Identifier Source: org_study_id

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