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Could a simple drug cut blood loss in leg fracture surgery?

NCT ID NCT07261930

Disease control Sponsor: Masaka Regional Referral Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at whether giving a single dose of tranexamic acid before surgery can reduce blood loss in adults with broken thigh bones. The trial involved 43 patients in Uganda who had open surgery to fix their fracture. The goal is to see if this common, low-cost drug can lower the need for blood transfusions and improve safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tranexamic acid
What this could lead to
If effective, this could provide a simple, low-cost way to reduce bleeding and transfusion needs during femoral fracture surgery in resource-limited settings.
What could go wrong
This is a small, completed Phase 4 trial with only 43 participants, so results may not apply broadly. The drug may not significantly reduce blood loss or transfusion needs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

43 people

The number who actually took part.

Started

Oct 2018

Finished

May 2019

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18 years and above * Patients with isolated, closed femoral shaft fractures * Scheduled for open intramedullary nail fixation at Mulago National Referral Hospital * Able and willing to provide written informed consent Exclusion Criteria: * Injury duration of more than one month * Patients undergoing repeat surgery for a femoral fracture * Pathological fractures of the femur * Patients undergoing ORIF for more than one fracture during the perioperative period * Known allergy to tranexamic acid * History of bleeding disorders * Presence of significant medical comorbidities (e.g., diabetes mellitus, history of deep vein thrombosis, or pulmonary embolism) * Current use of anticoagulant medications

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical Femoral Fractures hip fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Femoral fractures Hemorrhage, surgical Tranexamic acid use

Contacts and locations

Locations

  • Mulago National Referral Hospital

    Kampala, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.