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Tranexamic Acid and Vitamin K Injection for Upper Gastrointestinal Bleeding in Cirrhotic Patients

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Study Aim

This study aims to evaluate the effectiveness of Tranexamic Acid and Vitamin K Injection in reducing the rebleeding rate and need for blood transfusion at 5 days and 6 weeks in cirrhotic patients with upper gastrointestinal bleeding.

What is being tested

Tranexamic Acid and vitamin K

+ Placebo

Drug
Who is being recruted

Digestive System Diseases+6

+ Fibrosis

+ Gastrointestinal Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorTanta University
Study ContactRania M Elkafoury, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 2, 2024

Actual date on which the first participant was enrolled.

This study focuses on understanding how effective Tranexamic acid and Vitamin K injections are compared to a placebo in controlling upper gastrointestinal bleeding in Egyptian patients with liver cirrhosis. The study is particularly relevant as these patients often face such bleeding due to their condition, and finding an effective treatment could significantly improve their health outcomes. The research aims to determine if this combination can reduce bleeding and lower the risk of death in these patients more effectively than current standard practices. Participants in the study are divided into two groups, one receiving the Tranexamic acid and Vitamin K injections, and the other receiving a placebo, which is an inactive treatment. The treatment involves an initial dose of Tranexamic acid, followed by a maintenance dose, alongside Vitamin K injections, while the placebo group receives saline solutions. The study evaluates the patients' bleeding rates and mortality over a period of 5 days and again after 6 weeks. It also looks at other important factors like the need for blood transfusions, length of hospital stay, and any side effects experienced. To ensure safety, all participants receive standard care including medications and endoscopy, and their progress is closely monitored.

Official TitleEfficacy of Tranexamic Acid and Vitamin k Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study
NCT06881628
Principal SponsorTanta University
Study ContactRania M Elkafoury, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

194 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesFibrosisGastrointestinal DiseasesHemorrhageGastrointestinal HemorrhageLiver CirrhosisLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
Age >= 18 years

Liver cirrhosis

Upper gastrointestinal bleeding

8 exclusion criteria prevent from participating
DIC

Thromboembolic event

Pregnancy or lactation

End-stage renal disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients in this group have cirrhosis and are experiencing upper gastrointestinal bleeding. They will receive Tranexamic Acid and Vitamin K, along with standard care for their condition.

Group II

Placebo
This group includes 97 cirrhotic patients with UGIB. They receive IV saline and standard initial management, such as airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Tanta University Hospitals

Tanta, EgyptOpen Tanta University Hospitals in Google Maps
Recruiting
One Study Center
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