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

Inclusion Criteria3

  • Suspected severe endometriosis (based on clinical or radiological evidence or findings at previous diagnostic laparoscopy)
  • Proposed laparoscopic surgery to treat endometriosis of > 2 hours
  • Planned surgery under level 6 gynaecological surgeons’ operating lists

Exclusion Criteria5

  • Non consent
  • Non English speaking
  • Allergy or contraindication to tranexamic acid including: thrombophilia, previous/active thromboembolic disease, subarachnoid haemorrhage, malignancy or antithrombotic treatment
  • Hysterectomy planned as part of procedure
  • Other bleeding disorder

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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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