Clinical trial

Comparative Assessment of Chitosan-Based Dressing, Ankaferd and Tranexamic Acid in Achieving Hemostasis and Healing Following Dental Extraction in Liver Pre-Transplant Children

Name
PED 20-2D
Description
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
Trial arms
Trial start
2023-11-15
Estimated PCD
2024-01-20
Trial end
2024-05-20
Status
Completed
Phase
Early phase I
Treatment
tranexamic acid
Application of sterile gauze after extraction for hemostasis
Arms:
group 3 sterile gauze with tranexamic acid
Ankaferd Blood Stopper
Application of sterile gauze after extraction for hemostasis
Arms:
group 2 sterile gauze with ankaferd blood stopper
Chitosan
Application of sterile gauze after extraction for hemostasis
Arms:
group 1 sterile gauze with chitosan
Size
39
Primary endpoint
To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases
30 minutes
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 39, 'type': 'ACTUAL'}}
Updated at
2024-06-13

1 organization

3 products

1 indication

Indication
Cirrhosis
Product
Chitosan