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Tranexamic Acid for severe endometriosis surgery

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001318279
Enrollment
59
Registered
2018-08-06
Start date
2018-08-14
Completion date
2021-12-01
Last updated
2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Sponsors

The Royal Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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 criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026