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Blood thinners during prostate surgery: safe or not?

NCT ID NCT03297281

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether men with an enlarged prostate who take blood thinners can safely stay on them during laser surgery. About 389 men will be randomly assigned to either continue their blood thinners or stop them temporarily. The goal is to see if continuing blood thinners increases the risk of bleeding complications.

What this could mean

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

Active substance
oral anticoagulants (blood thinners)
What this could lead to
If successful, this could show that continuing blood thinners during laser prostate surgery is safe, simplifying care for patients on these medications.
What could go wrong
This is a mid-sized trial, not a final proof. Results may not apply to all patients, and bleeding risks remain possible.

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

About 389 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2017

Expected to finish

May 2028

An estimate. End dates often move.

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 years and older

Sex

Male participants only

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: * Prostate volume \< or = 30 gr * Micturition disorders resistant to medical treatment related to HBP and/or complications related to BPH (retention, lithiasis...) * Patient candidate for photovaporization of the prostate * Patient under treatment AVK (Anti Vitamin K) for more than 3 months with an objective of INR (International Normalized Ratio) between 2 and 3 or patient under DOACs (Direct Oral Anti-coagulants) for more than 3 months * Unprotected major * Patient affiliated to a social security scheme or equivalent * Patient is willing and able to comply with all study requirements and to sign a study-specific informed consent form. Exclusion Criteria: * History of prostate cancer * Previous pelvic radiotherapy * History of stenosis of the urethra * Patient with one or more bladder polyps * Patient under antiplatelet agent other than aspirin * Allergy to heparin or history of heparin-induced thrombocytopenia * Patients under anticoagulant injectable therapy at baseline (heparin, LMWH (Low Molecular Weight Heparin), fondaparinux) * Any mechanical prosthetic heart valve * Stroke (ischemic or hemorrhagic), systemic embolism or transient ischemic attack within past 12 weeks * Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks * Major bleeding within past 6 weeks * Severe renal insufficiency (calculated creatinine clearance \< 30 mL / min) * Thrombocytopenia (platelet count \< 100 x 10\^9 / L) * Life expectancy \< 1 month * Condition that impairs compliance with trial protocol (e.g. cognitive impairment, uncontrolled psychiatric condition, geographic inaccessibility) * Contra-indication to PVP surgery or contra-indication to general anesthesia * Protected patients : majors under some form of guardianship * Patient participating in another clinical study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinique Pasteur

    RECRUITING

    Toulouse, 31 076, France

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