Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug could help heart surgery patients who Don't respond to standard blood thinner

NCT ID NCT06096116

Disease control Sponsor: Octapharma Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a drug called Atenativ, made from human plasma, in 120 adults who are resistant to heparin during planned heart surgery. Heparin is a blood thinner used to prevent clots during surgery, but some patients don't respond well. The drug aims to restore heparin's effectiveness, reducing the need for additional treatments like frozen plasma. The trial is double-blind and placebo-controlled, meaning neither patients nor doctors know who gets the real drug.

What this could mean

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

Active substance
human plasma-derived antithrombin (Atenativ)
What this could lead to
If it works, this could provide a standard treatment for heparin resistance during cardiac surgery, reducing the need for additional blood products and improving surgical safety.
What could go wrong
This is a Phase 3 trial, but with only 120 participants, results may not apply to all patients. The treatment is derived from human plasma, which carries a small risk of allergic reactions or infection transmission.

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

About 120 people

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

Started

Aug 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

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 85 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. Planned cardiac surgery with CPB 2. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH) 3. Patients between 18 and 85 years of age, inclusive 4. Freely given written or electronic informed consent 5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery Exclusion Criteria: 1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery: 1. vitamin K antagonists (within 3 days) 2. direct oral anticoagulants (within 2 days) 3. thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment 4. ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment 5. glycoprotein IIb/IIIa antagonist (within 24 hours) 2. Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder) 3. Renal insufficiency, defined as serum creatinine level \>2.0 mg/dL 4. Thrombocytosis, defined as platelet count \>400,000 per μL 5. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid 6. History of anaphylactic reaction(s) to blood or blood components 7. Refusal to receive transfusion of blood or blood-derived products 8. Current participation in another interventional clinical trial or previous participation in the current trial 9. Treatment with any IMP within 30 days prior to screening visit

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acquired antithrombin deficiency are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

hereditary antithrombin deficiency

As listed by the trial registrant

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

Acquired antithrombin deficiency

How to take part

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

  1. The places running it

    25 sites in 9 countries. 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

  • Atrium Health Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • CHU de Reims, Hôpital Robert Debré

    TERMINATED

    Reims, France

  • CHU de Rennes

    WITHDRAWN

    Rennes, France

  • Center of Cardiovascular and Transplant Surgery

    RECRUITING

    Brno, Czechia

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710-1000, United States

  • Hospital of Lithuanian university of Health sciences Kauno Klinikos

    RECRUITING

    Kaunas, Lithuania

  • Institute for Cardiovascular Diseases C.C. Iliescu

    RECRUITING

    Bucharest, Romania

  • Institute for Clinical and Experimental Medicine

    RECRUITING

    Prague, Czechia

  • Institute of Cardiovascular Diseases Vojvodina

    NOT_YET_RECRUITING

    Kamenitz, Serbia

  • Kingston Health Sciences Centre

    RECRUITING

    Kingston, Ontario, K7L2V7, Canada

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, H1T1C8, Canada

  • OU Health University of Oklahoma Medical Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Royal Columbian Hospital

    RECRUITING

    New Westminster, British Columbia, V3L0A4, Canada

  • Royal Papworth Hospital

    RECRUITING

    Cambridge, United Kingdom

  • Stanford University School of Medicine

    RECRUITING

    Stanford, California, 94305-5101, United States

  • The James Cook University Hospital

    RECRUITING

    Middlesbrough, United Kingdom

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G2C4, Canada

  • University Hospital Coventry and Warwickshire

    RECRUITING

    Coventry, United Kingdom

  • University Hospital Innsbruck

    RECRUITING

    Innsbruck, Austria

  • University Medical Centre Ljubljana

    RECRUITING

    Ljubljana, Slovenia

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Vienna General Hospital AKH, Medical University of Vienna

    RECRUITING

    Vienna, Austria

  • Vilnius University hospital Santaros Klinikos

    RECRUITING

    Vilnius, Lithuania