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Simple drug may cut bleeding in broken leg surgery

NCT ID NCT07625709

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether giving tranexamic acid before surgery can reduce blood loss in people with broken thigh or shin bones. Fifty-four patients received either the drug or a placebo before their operation. Researchers measured blood loss during and after surgery, as well as changes in hemoglobin levels and transfusion needs.

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 it works, this could show that a single dose of tranexamic acid before surgery reduces bleeding and the need for blood transfusions in patients with leg fractures.
What could go wrong
This is a small, completed study with only 54 participants, so results may not apply to everyone. There is also a risk of side effects like blood clots or allergic reactions.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

54 people

The number who actually took part.

Started

Jan 2023

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 60 years

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: * Patients aged 16-60 years * Patients with isolated diaphyseal fracture (Shaft fracture of femur or Shaft fracture of tibia) * Patients planned for reamed intramedullary nailing * Patients willing to provide informed consent Exclusion Criteria: * Patients with polytrauma * Fractures requiring open reduction * Gustilo-Anderson Grade III open fractures * Known history of coagulopathy * International Normalized Ratio (INR) \> 1.2 * Current use of anticoagulant therapy * Current use of antiplatelet therapy * Presence of major hepatic failure * Presence of major renal failure * Patients unwilling or unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical bone fracture Femoral Fractures femoral neck fracture Postoperative Hemorrhage tibia fracture

As listed by the trial registrant

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

Contacts and locations

Locations

  • Dhulikhel Hospital, Kathmandu University Hospital

    Dhulikhel, Bagmati, 45200, Nepal

More trials for these conditions

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