Liver CirrhosisEarly Phase 1NCT06457360
Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children
A Early Phase 1 study testing tranexamic acid, Ankaferd Blood Stopper and Chitosan in people with Liver Cirrhosis, run by British University In Egypt at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- tranexamic acid, Ankaferd Blood Stopper and Chitosan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2023to 20 May 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of Chitosan-Based Dressing, Ankaferd and Tranexamic Acid in Achieving Hemostasis and Healing Following Dental Extraction in Liver Pre-Transplant Children
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
- Being tested
- tranexamic acid, Ankaferd Blood Stopper, Chitosan
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acidDrug
Application of sterile gauze after extraction for hemostasis
Ankaferd Blood StopperDrug
Application of sterile gauze after extraction for hemostasis
ChitosanDrug
Application of sterile gauze after extraction for hemostasis
| Study group | Role | What they receive |
|---|---|---|
| group 1 sterile gauze with chitosan | Experimental | Chitosan-based dressing gauze after extraction in patients with end stage liver disease Receives: 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 Receives: 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 Receives: Drug: tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (1)
pain score assessment
Pain scores will be assessed using Visual Analog Scale from 0 to 10 pain score for seven days following extraction where 0 is no pain and 10 is maximum pain
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Nov 2023
- Primary completion20 Jan 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- noha S Kabil, Principal investigator, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457360
- Sponsor's protocol ID
- PED 20-2D
- Status last verified
- Oct 2024
- First submitted
- 22 Nov 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Chitosan-Based Dressing, Ankaferd and Tranexamic Acid in Achieving Hemostasis and Healing Following Dental Extraction in Liver Pre-Transplant Children
- ClinicalTrials.gov ID
- NCT06457360
- Acronym / sponsor ID
- PED 20-2D
- Conditions
- Liver Cirrhosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 sterile gauze with chitosan | Experimental | Drug: ChitosanChitosan-based dressing gauze after extraction in patients with end stage liver disease |
| group 2 sterile gauze with ankaferd blood stopper | Experimental | Drug: Ankaferd Blood Stopperankaferd blood stopper dressing gauze after extraction in patients with end stage liver disease |
| group 3 sterile gauze with tranexamic acid | Active comparator | Drug: tranexamic acidtranexamic acid dressing gauze after extraction in patients with end stage liver disease |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tranexamic acidApplication of sterile gauze after extraction for hemostasis | Drug | group 3 sterile gauze with tranexamic acid |
| Ankaferd Blood StopperApplication of sterile gauze after extraction for hemostasis | Drug | group 2 sterile gauze with ankaferd blood stopper |
| ChitosanApplication of sterile gauze after extraction for hemostasis | Drug | group 1 sterile gauze with chitosan |
Primary outcome
To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases
Time frame: 30 minutes
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
1 secondary outcome
pain score assessment
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
noha S Kabil principal investigator
British University In Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing tranexamic acid, Ankaferd Blood Stopper and Chitosan in people with Liver Cirrhosis, run by British University In Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.