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Study on Tranexamic Acid to Reduce Bleeding and Transfusion Needs in Patients Undergoing Major Abdominal Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing major abdominal surgeries, such as esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, and hepatectomy. These procedures often involve significant bleeding, which may require blood transfusions. The study is investigating the use of Tranexamic Acid, a medication that helps reduce bleeding, to see if it can decrease the need for blood transfusions during and after these surgeries.

The purpose of the study is to determine if administering Tranexamic Acid during surgery can effectively reduce blood loss and the subsequent need for transfusions. Participants in the study will receive either the medication or a placebo. The treatment will be given through an intravenous infusion, which means it will be delivered directly into the bloodstream through a vein. The study will monitor the amount of blood loss, the number of blood transfusions needed, and any complications that may arise during the hospital stay.

In addition to Tranexamic Acid, the study will also use a solution called Sodium Chloride, commonly known as saline, which is often used in medical settings to maintain fluid balance. The trial aims to provide valuable information on how to better manage bleeding during major abdominal surgeries, potentially improving patient outcomes and reducing the need for blood transfusions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, planned surgery type, renal function, and consent.

    A negative pregnancy test is required for women of childbearing potential, and effective contraceptive measures must be agreed upon.

  2. Step 2

    Pre-surgery preparation

    Before surgery, preparation involves understanding the procedure and the role of tranexamic acid in reducing blood loss.

    The medication is administered as a solution for injection/infusion.

  3. Step 3

    Surgery day

    On the day of surgery, tranexamic acid is given through intravenous perfusion to help reduce bleeding during the operation.

    The primary goal is to minimize the need for blood transfusions during and after surgery.

  4. Step 4

    Post-surgery monitoring

    After surgery, monitoring includes checking for any need for blood transfusions and assessing recovery.

    The focus is on the number of transfusions, blood loss, and any complications within 30 days.

  5. Step 5

    Follow-up and evaluation

    Follow-up involves evaluating the duration of hospital stay, operation and anesthesia time, and overall recovery.

    Quality of life and other health indicators are assessed to determine the effectiveness of the treatment.

Who can join the trial?

5 criteria

  • Patients must be **18 years or older**.
  • Patients should have a **planned elective surgery**. This includes surgeries like esophagectomy (removal of part of the esophagus), gastrectomy (removal of part of the stomach), colectomy (removal of part of the colon), rectal resection (removal of part of the rectum), pancreatic resection (removal of part of the pancreas), or hepatectomy (removal of part of the liver).
  • Patients need to have **adequate kidney function**. This is checked by measuring a substance in the blood called **serum creatinine**, which should be less than 250 micromoles per liter (or 2.82 milligrams per deciliter).
  • Patients must provide **written informed consent** before being randomly assigned to a group in the study. This means they agree to participate after understanding the study details.
  • Women who can have children must have a **negative pregnancy test** within 14 days before starting the study treatment. They must also agree to use very effective birth control methods during the study. These methods should have a failure rate of less than 1% per year and can include having a partner who has had a vasectomy or choosing not to have heterosexual intercourse during the study.

Who cannot join the trial?

9 criteria

  • Patients who are not undergoing major abdominal surgery, such as surgery on the esophagus, stomach, colon, rectum, pancreas, or liver, cannot participate.
  • Patients who have a known allergy or adverse reaction to **Tranexamic Acid**, a medication used to reduce bleeding, cannot participate.
  • Patients with a history of blood clotting disorders, which means their blood clots too easily, cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with severe kidney problems, which means their kidneys do not work well, cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent heart attack or stroke, which are serious conditions affecting the heart or brain, cannot participate.
  • Patients with uncontrolled high blood pressure, meaning their blood pressure is too high and not managed, cannot participate.
  • Patients who are unable to give informed consent, which means they cannot understand and agree to the trial, cannot participate.
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Investigated drugs

Tranexamic Acid is a medication used in this trial to help reduce bleeding during and after major abdominal surgeries. The goal is to see if it can decrease the need for blood transfusions by minimizing blood loss during the operation.

What is already known about the treatment

Tranexamic Acid – Tranexamic Acid is administered intravenously during surgery to help reduce bleeding. It is currently being studied in clinical trials for its effectiveness in decreasing the need for blood transfusions during major abdominal surgeries, such as esophagectomy and hepatectomy. The main therapeutic indication is to minimize blood loss and transfusion requirements in these surgical procedures. At the molecular level, Tranexamic Acid works by inhibiting the breakdown of blood clots, which helps to control bleeding. It is classified as an antifibrinolytic agent, meaning it prevents the dissolution of fibrin, a protein involved in blood clotting.

Investigated diseases

  • Esophagectomy

    This is a surgical procedure to remove part or all of the esophagus, often due to cancer or severe damage. The surgery involves removing the affected section and reconstructing the digestive tract, usually by pulling up the stomach or using a piece of the intestine. Recovery can be complex, with potential complications such as infection or leakage at the surgical site. Patients may experience difficulty swallowing and require dietary adjustments. The procedure can significantly impact the patient's quality of life and requires careful postoperative management.

  • Gastrectomy

    This surgery involves the removal of part or all of the stomach, typically due to cancer, ulcers, or other severe stomach issues. The operation can lead to changes in digestion and nutrient absorption, requiring dietary modifications. Patients may experience symptoms like nausea, vomiting, or weight loss post-surgery. The procedure can also affect the body's ability to produce certain digestive enzymes. Recovery involves gradual reintroduction of foods and monitoring for complications such as infection or nutritional deficiencies.

  • Colectomy

    A surgical procedure to remove all or part of the colon, often performed to treat conditions like cancer, diverticulitis, or inflammatory bowel disease. The surgery can be done through open surgery or laparoscopically, depending on the case. Postoperative recovery may include changes in bowel habits and the need for a temporary or permanent colostomy. Patients may experience abdominal pain and require a gradual return to normal activities. Long-term effects can include changes in digestion and bowel function.

  • Rectal Resection

    This surgery involves removing part or all of the rectum, usually due to cancer or other severe rectal diseases. The procedure may involve creating a new pathway for waste to leave the body, sometimes requiring a temporary or permanent colostomy. Recovery can be challenging, with potential complications such as infection or bowel dysfunction. Patients may need to adjust their diet and lifestyle to accommodate changes in bowel habits. The surgery can significantly impact quality of life and requires careful follow-up care.

  • Pancreatic Resection

    A surgical procedure to remove part of the pancreas, often due to cancer or chronic pancreatitis. The surgery can affect the pancreas's ability to produce insulin and digestive enzymes, leading to diabetes or digestive issues. Recovery involves managing pain and monitoring for complications such as infection or bleeding. Patients may need to take enzyme supplements and adjust their diet to aid digestion. The procedure can have long-term effects on metabolism and overall health.

  • Hepatectomy

    This is the surgical removal of part or all of the liver, typically performed to treat liver cancer or severe liver damage. The liver has a remarkable ability to regenerate, but recovery can still be complex, with risks of bleeding and infection. Patients may experience fatigue and require close monitoring of liver function post-surgery. The procedure can impact the body's ability to process nutrients and medications. Long-term follow-up is essential to ensure proper liver function and overall health.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509970-43-01Protocol codeKKSH-190Estimated enrolment850 patientsSponsorMartin-Luther-Universitaet Halle-Wittenberg

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