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Adjunctive Tranexamic Acid for Haemorrhage Control During Myomectomy

Adjunctive Tranexamic Acid for Haemorrhage Control During Myomectomy: A Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202607470597411
Enrollment
108
Registered
2026-07-16
Start date
2021-06-21
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Surgery Fertility-female Uterine Fibroids (Leiomyomata), Postoperative Anaemia, Intraoperative Haemorrhage.

Interventions

Intravenous Tranexamic Acid
Normal Saline

Sponsors

Wasiu Onasanya
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Symptomatic women of reproductive age scheduled for open abdominal myomectomy Confirmed diagnosis of uterine fibroids via ultrasonography Provision of written informed consent prior to enrollment

Exclusion criteria

Exclusion criteria: Postmenopausal status Current or recent use of gonadotropin-releasing hormone (GnRH) analogues History of previous myomectomy Underlying thromboembolic disease, ischemic heart disease, hepatic insufficiency, chronic kidney disease, or active malignancy Documented hypersensitivity to tranexamic acid (TXA) Maternal body mass index (BMI) > 30 kg/m² Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates, or all-trans retinoic acid within 2 weeks prior to surgery

Design outcomes

Primary

MeasureTime frame
Intraoperative estimated blood loss (EBL)

Secondary

MeasureTime frame
Postoperative packed cell volume / haematocrit (HCT) and haemoglobin (Hb) concentrations;Allogeneic blood transfusion requirements and the total number of blood units transfused;Total operative duration and postoperative length of hospital stay

Countries

Nigeria

Contacts

Public ContactAdeniyi Akiseku

Corresponding Author Olabisi Onabanjo University Teaching Hospital

niyikepler@yahoo.com+2348036103799

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026