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New blood thinner aims to prevent clots after knee surgery

NCT ID NCT06825416

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 2 times

Summary

This study tested a new drug called SHR-2004 to prevent dangerous blood clots in people undergoing elective total knee replacement. Over 1,100 adults participated, receiving either SHR-2004 or a standard blood thinner. The goal was to see if SHR-2004 could reduce clots in the legs or lungs while keeping bleeding risks low.

What this could mean

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

Active substance
SHR-2004 injection
What this could lead to
If it works, SHR-2004 could offer a new option to prevent blood clots after knee replacement, potentially reducing the risk of deep vein thrombosis and pulmonary embolism.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. The main risk is bleeding, as with any blood thinner. It may not prove safer or more effective than existing treatments.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,165 people

The number who actually took part.

Started

Mar 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 80 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: 1. Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing; 2. Planned elective schedule total knee arthroplasty (TKA) patients; 3. Men or women who are ≥ 18 years old and \< 80 years old on the day of signing the informed consent form. Exclusion Criteria: 1. Unable to receive CT angiography of both lower limbs; 2. Malignant tumor within one year of the screening; 3. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening; 4. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding; 5. History of drug abuse; 6. Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

venous thromboembolism Venous Thrombosis

As listed by the trial registrant

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

Contacts and locations

Locations

  • Fourth Medical Center of Chinese People's Liberation Army General Hospital

    Beijing, Beijing Municipality, 100048, China

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008, China