In short
This article provides information about ongoing clinical trials investigating ways to reduce bleeding during major abdominal surgeries. Currently, one trial is exploring the use of Tranexamic Acid to minimize blood loss and decrease the need for blood transfusions in patients undergoing procedures such as removal of parts of the esophagus, stomach, colon, rectum, pancreas, or liver.
Clinical trial locations
Study on Tranexamic Acid to Reduce Bleeding and Transfusion Needs in Patients Undergoing Major Abdominal Surgery
This clinical trial is focused on patients who are scheduled to undergo major abdominal surgeries. These operations include removal of parts of the esophagus, stomach, colon, rectum, pancreas, or liver. Such procedures often involve significant bleeding, which can lead to the need for blood transfusions during or after surgery.
Main focus: The trial aims to investigate whether Tranexamic Acid, a medication that helps reduce bleeding, can effectively decrease blood loss during surgery and lower the need for blood transfusions. Participants will receive either the active medication or a placebo through an intravenous infusion directly into the bloodstream. The study will closely monitor the amount of blood lost, how many transfusions are needed, and whether any complications occur during the hospital stay.
Investigational drug: Tranexamic Acid is the medication being tested. It works by preventing the breakdown of blood clots, helping to control bleeding during the operation. The drug is classified as an antifibrinolytic agent.
Who can participate: To join this trial, patients must be at least 18 years old and scheduled for one of the eligible abdominal surgeries. They need to have adequate kidney function, measured by blood tests showing serum creatinine levels below 250 micromoles per liter. Written informed consent is required before joining. Women of childbearing age must have a negative pregnancy test within 14 days before starting treatment and agree to use highly effective birth control methods with a failure rate of less than 1% per year throughout the study.
Who cannot participate: Patients are excluded if they are not undergoing one of the specified major abdominal surgeries or if they have a known allergy to Tranexamic Acid. Those with a history of blood clotting disorders, where blood clots form too easily, cannot join. Pregnant or breastfeeding women are not eligible. Patients with severe kidney problems, recent heart attacks or strokes, or uncontrolled high blood pressure are also excluded. Additionally, those currently participating in another clinical trial or unable to provide informed consent cannot take part.
What to expect: The trial follows patients through several stages. Upon joining, eligibility is confirmed and baseline health measures are recorded. Before surgery, patients learn about the procedure and how Tranexamic Acid may help. On the day of surgery, the medication is administered intravenously to reduce bleeding. After surgery, medical staff monitor recovery, tracking any need for blood transfusions and checking for complications within 30 days. Follow-up evaluations assess hospital stay duration, operation time, overall recovery, and quality of life to determine the treatment's effectiveness.
Summary
Currently, there is one active clinical trial addressing procedural haemorrhage related to major abdominal surgeries. This trial is being conducted in Germany and focuses specifically on the use of Tranexamic Acid to reduce bleeding and transfusion requirements. The study targets patients undergoing significant operations such as esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, and hepatectomy. The concentration of research on Tranexamic Acid reflects ongoing efforts to improve surgical outcomes by minimizing blood loss and reducing the need for transfusions, which can carry their own risks and complications. Patients interested in participating should discuss eligibility criteria with their healthcare providers.
