Tranexamic Acid and Vitamin K Injection for Upper Gastrointestinal Bleeding in Cirrhotic Patients
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.
Tranexamic Acid and vitamin K
+ Placebo
Digestive System Diseases+6
+ Fibrosis
+ Gastrointestinal Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.194 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy 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