Upper Gastrointestinal Bleeding (UGIB)Phase 4NCT06881628
Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients
A Phase 4 study testing Tranexamic Acid and vitamin K in people with Upper Gastrointestinal Bleeding (UGIB) and Variceal Bleeding, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding (UGIB), Variceal Bleeding, Cirrhosis
- What is being tested?
- Tranexamic Acid and vitamin K
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2024to 30 Dec 2025
- Phase
- Phase 4
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Liver cirrhosis
- Upper gastrointestinal bleeding
Who cannot join
- Patients aged < 18 years
- Allergy to tranexamic acid
- Allergy to vitamin K injection
- DIC.
- Thromboembolic event.
- Pregnancy or lactation.
- End-stage renal disease.
- Unwilling to participate in our study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbyea, 31516
Dina H Ziada, MD, 00201117109990, dina.ziada@med.tanta.edu.eg
Rania M Elkafoury, MD
About this study
Official title: Efficacy of Tranexamic Acid and Vitamin k Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study
The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients.
Researchers will compare the bleeding and mortality rates (at 5 days and 6 weeks post endoscopic intervention for UGIB) between patients receiving tranxemic acid and vitamin K injection and patients receiving placebo.
Read more
Participants presenting with variceal bleeding will be randomly assigned to receive tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h or matching placebo group receiving IV saline. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.
Follow-up All patients will be kept at the hospital for at least 5 days from the index bleed and will be discharged if no other reason was observed to keep them at the hospital.
The rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate were evaluated and compared across the groups.
At discharge, all patients will be started on nonselective beta-blockers if there was no contraindication. They will be given instructions to attend to hospital if they noticed any melena or hematemesis.
Second follow-up after 6 weeks for the rebleeding rate and mortality related to bleeding rate.
- Being tested
- Tranexamic Acid and vitamin K, Placebo
- Keywords
- Variceal bleeding, Tranexamic acid and vitamin K, Liver cirrhosis
- Medical subject headings
- Gastrointestinal Hemorrhage, Fibrosis, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid and vitamin KDrug
Tranxemic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection (10 mg daily of vitamin K for 24-48 h) along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients.
Patients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate.
PlaceboDrug
Intravenous saline over 24-48 hours along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients.
Patients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid and vitamin K | Experimental | 97 cirrhotic patients presenting with UGIB receiving tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24-48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy. Receives: Drug: Tranexamic Acid and vitamin K |
| Placebo | Placebo comparator | 97 cirrhotic patients presenting with UGIB receiving IV saline besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate
The rate of rebleeding and need for blood transfusion at 5 days and 6 weeks will be evaluated and compared across the groups.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Mortality rate
The mortality rates at 5 days and 6 weeks will be evaluated and compared across the groups.
Measured: through study completion, an average of 1 year
adverse effects
Drug adverse effects at 5 days and 6 weeks will be evaluated and compared across the groups.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start2 Dec 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal Bleeding (UGIB)Studies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
- Investigators
- Rania M Elkafoury, MD, Principal investigator, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881628
- Sponsor's protocol ID
- 36264PR982/12/24
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No