RecruitingPhase 4ACTRN12618001318279

Tranexamic Acid for severe endometriosis surgery

Intra-operative intravenous tranexamic acid during laparoscopic surgery for severe endometriosis - a double-blinded randomized placebo controlled trial


Sponsor

The Royal Women's Hospital

Enrollment

200 participants

Start Date

Aug 14, 2018

Study Type

Interventional

Conditions

Summary

Tranexamic acid is a medication that can help reduce bleeding by stopping the breakdown of blood clots. It has been shown to reduce bleeding from many types of surgeries (such as heart, knee, hip, trauma and some gynaecological surgeries). When it has been used to reduce bleeding in surgery, tranexamic acid has not caused an increase in bad outcomes (adverse events). No one has yet done a study to see if tranexamic acid also helps to reduce bleeding in keyhole surgery for severe endometriosis. If less bleeding occurs using tranexamic acid during these surgeries it may also help to make operations shorter and less likely to have complications. We predict that tranexamic acid will reduce blood loss in keyhole surgery for severe endometriosis. This study is a randomized controlled research project where we randomly put people who are going to have endometriosis surgery into two groups. One group will get the treatment (tranexamic acid) during the surgery and the other group will get a placebo (a medication with no active ingredients). This is a double-blinded study which means both the participants and their doctors do not know which treatment the participants are receiving. We will weigh the blood loss from the surgeries to compare between the two groups if the tranexamic acid does indeed reduce blood loss in this type of surgery. We will also see if there are other differences between the groups such as the time it takes to finish the surgery, the rates of complications and how long the participants need to stay in hospital.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for women with severe endometriosis who are scheduled for extended keyhole surgery (laparoscopy expected to take more than 2 hours). Endometriosis is a condition where tissue similar to the lining of the uterus grows in other places in the body — often the pelvis — causing significant pain and sometimes affecting fertility. Surgery to remove this tissue can involve considerable blood loss, which can make the operation longer and more complex. This trial tests whether giving tranexamic acid — a medication that helps blood clot and reduces bleeding — during surgery can meaningfully reduce blood loss in these complex operations. Tranexamic acid is already used safely in many other types of surgery. Participants are randomly assigned to receive either tranexamic acid or a placebo, and neither they nor their surgeon knows which they received until after the study. The main outcome is the amount of blood lost during surgery, measured by weighing surgical materials. You may be eligible if you are a woman with suspected severe endometriosis (based on clinical assessment, imaging, or a previous diagnostic laparoscopy), are scheduled for laparoscopic surgery expected to last more than 2 hours, and do not have a planned hysterectomy. Women with clotting disorders, previous blood clots, allergy to tranexamic acid, or who are non-English speaking are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Tranexamic Acid. 1 gram administered IV as a single dose immediately following skin incision.

Tranexamic Acid. 1 gram administered IV as a single dose immediately following skin incision.


Locations(1)

The Royal Women's Hospital - Parkville

VIC, Australia

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ACTRN12618001318279


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