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Can a clotting drug stop bleeding in patients on blood thinners?

NCT ID NCT04867837

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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called OCTAPLEX to stop major bleeding in people taking blood thinners (factor Xa inhibitors). The trial planned to enroll 100 patients and compare two different doses. Unfortunately, the study was terminated early, so we have less information than hoped. The goal was to see if OCTAPLEX could safely and effectively control bleeding in these emergency situations.

What this could mean

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

Active substance
OCTAPLEX (a blood clotting concentrate)
What this could lead to
If successful, this could provide a way to quickly reverse the effects of certain blood thinners during life-threatening bleeding.
What could go wrong
The study was terminated early, so results are limited. It only included patients on specific blood thinners, so findings may not apply to everyone.

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

100 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 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 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: 1. Patients on oral factor Xa inhibitor therapy and with known or suspected baseline anti-factor Xa activity of at least 100 ng/mL: \- Patients who received or who are believed by the investigator to have received a dose of oral factor Xa inhibitor and who have a baseline anti- factor Xa activity of at least 100 ng/mL according to the locally available test (e.g., chromogenic assay) performed outside of the study as part of standard of care OR * Patients who received or who are believed by the investigator to have received their latest dose of oral factor Xa inhibitor (e.g., rivaroxaban ≥10 mg, apixaban ≥2.5 mg, edoxaban ≥30 mg) ≤8 hours prior to enrolment OR -Patients who received or who are believed by the investigator to have received their latest dose of oral factor Xa inhibitor (e.g., rivaroxaban ≥10 mg, apixaban ≥2.5 mg, edoxaban ≥30 mg) \>8 hours prior to enrolment or at an unknown time, but for whom the investigator suspects a baseline anti- factor Xa activity of at least 100 ng/mL and assesses that the administration of OCTAPLEX is clinically indicated 2. Aged ≥18 years 3. Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legally authorised representative on their behalf -Wherever possible, prospective written informed consent will be obtained before enrolment from the patient or, if they are incapable of providing it, from their legally authorised representative -If prospective written informed consent is not possible, deferred consent procedures will be permitted outside the US if approved by the local ethics committee or otherwise permitted under local regulations -When deferred consent procedures are used outside the US, written informed consent should be obtained from the patient as soon as they recover the capacity to provide it, or otherwise from their legally authorised representative 4. Patients who have acute major bleeding defined as follows: * Bleeding that is life-threatening or uncontrolled, e.g., with signs or symptoms of haemodynamic compromise, such as severe hypotension, poor skin perfusion, or low cardiac output that cannot be otherwise explained OR \- Symptomatic bleeding in critical organs (intracranial, intraspinal, intraocular, gastrointestinal, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome) OR \- Acute overt bleeding associated with a fall in haemoglobin (Hgb) level of ≥2 g/dL, OR a Hgb level ≤8 g/dL if no baseline Hgb level is available, OR in the opinion of the investigator that the patient's Hgb level will fall to ≤8 g/dL with resuscitation Exclusion Criteria: 1. Patients with 'Do not resuscitate' (DNR) orders 2. Patients with acute trauma for which reversal of DOAC therapy with factor Xa inhibitor alone would not be expected to control the bleeding event 3. Hgb decrease without accompanying evidence of source of bleeding 4. Acute coronary syndrome, ischaemic stroke or venous thromboembolism (VTE) within the preceding 3 months 5. Patients with a history, within the last 3 months, of disseminated intravascular coagulation (DIC) or hyperfibrinolysis 6. Patients with a known congenital bleeding disorder 7. Known inhibitors to coagulation factors II, VII, IX, or X; heparin-induced, type II thrombocytopenia; or immunoglobulin A (IgA) deficiency with known antibodies against IgA 8. Known hypersensitivity to plasma-derived products or heparin 9. Patients who received haemostatic agents, including plasma, platelets, PCC, activated PCC (aPCC), recombinant factor VIIa, or recombinant factor Xa inactivated-zhzo (andexanet alfa), for the current bleeding event prior to enrolment (antifibrinolytic drugs and local haemostatic agents are allowed) 10. Patients who received ticlopidine within 14 days, prasugrel within 7 days, ticagrelor within 5 days, dipyridamole within 1 day or cangrelor within 1 hour preceding the bleeding event 11. Patients on enoxaparin therapy for thromboembolic prophylaxis 12. A score of less than 7 on the Glasgow Coma Scale in non-intubated patients or an estimated intracerebral haematoma volume of more than 60 mL. (Patients intubated or sedated at the time of screening may be enrolled if intubation or sedation were done for non-neurologic reasons) 13. Patients with expected survival of less than 24 hours, in the opinion of the investigator (in collaboration with other medical experts as appropriate per usual local practice) 14. Patients scheduled to undergo surgery in less than 12 hours, with the exception of minor surgeries and invasive procedures which are allowed for diagnostic or therapeutic reasons or if intended to address a second (non-index) bleeding event 15. Patients who are pregnant or breastfeeding at the time of enrollment 16. Patients previously enrolled in this study 17. Patients participating in another interventional clinical treatment study currently or during the past 1 month prior to study inclusion

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As listed by the trial registrant

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

Acute major bleeding

Contacts and locations

Locations

  • Ankara University Faculty of Medicine

    Ankara, 6230, Turkey (Türkiye)

  • Ascension Seton Medical Center Austin

    Austin, Texas, 78712, United States

  • Azienda Ospedaliero -Universitaria di Modena

    Modena, 41125, Italy

  • Azienda Ospedaliero-Universitaria Senese

    Siena, 53100, Italy

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Centre Hospitalier Universitaire Francois Mitterand

    Dijon, 21000, France

  • Clinical Center University of Sarajevo

    Sarajevo, 71000, Bosnia and Herzegovina

  • Clinical Hospital Dubrava

    Zagreb, 10000, Croatia

  • Clinical Research Center at Special Hospital Stefan Zeromski

    Krakow, 31-913, Poland

  • Dell Seton Medical Center at the University of Texas

    Austin, Texas, 78712, United States

  • Ege University Faculty of Medicine

    Izmir, 35100, Turkey (Türkiye)

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Harbor-UCLA Medical Center

    Torrance, California, 90509, United States

  • Health Sciences University Bursa High Specialization Training and Research Hospital

    Bursa, 16300, Turkey (Türkiye)

  • Heidelberg University Hospital Neurologische Universitätsklinik

    Heidelberg, 69120, Germany

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415, United States

  • Hospital Dr. Peset

    Valencia, 46017, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 00261, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026, Spain

  • Istanbul University Istanbul Faculty of Medicine Department of Internal Diseases, Division of Hematology

    Istanbul, 34093, Turkey (Türkiye)

  • K.Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 159, Georgia

  • Kahramanmaraş Sütçü İmam University Faculty of Medicine

    Kahramanmaraş, 46040, Turkey (Türkiye)

  • Karadeniz Technical University

    Trabzon, 61080, Turkey (Türkiye)

  • Klinikum Klagenfurt am Wörthersee Anästhesiologie und Intensivmedizin

    Klagenfurt, 9020, Austria

  • LTS ,, Israel-Geoargian Medical Research clinic Helsicore"

    Tbilisi, 112, Georgia

  • Medical and Diagnostic Center of Private Enterprise of Private Manufacturing Company "Acinus"

    Kropyvnytskyi, 26006, Ukraine

  • Mersin University Faculty of Medicine

    Mersin, 33343, Turkey (Türkiye)

  • Military Institute of Medicine

    Warsaw, 04-141, Poland

  • New Hospitals

    Tbilisi, 114, Georgia

  • North Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital

    Basingstoke, Hampshire, RG24 9NA, United Kingdom

  • Nottingham University Hospital

    Nottingham, NG51PB, United Kingdom

  • OU Health - University of Oklahoma Medical Center

    Oklahoma City, Oklahoma, 73104, United States

  • Ondokuz Mayıs University Faculty of Medicine

    Samsun, 55280, Turkey (Türkiye)

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Ospedale Maggiore - IRCCS Istituto di Scienze Neurologiche di Bologna

    Bologna, 40133, Italy

  • Ospedale Santa Maria della Misericordia

    Perugia, 06156, Italy

  • Ośrodek Badań Klinicznych BD Research

    Iława, 14-200, Poland

  • Pineo Medical Ecosystem

    Tbilisi, 00108, Georgia

  • Public Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council

    Ivano-Frankivsk, 76025, Ukraine

  • Public Non-profit Enterprise Clinical Emergency Care Hospital of Dnipro City Counsil

    Dnipro, 49006, Ukraine

  • Public Non-profit Enterprise Kyiv City Clinical Hospital #17 of Kyiv City Council Executive Body

    Kyiv, 01133, Ukraine

  • Public Non-profit Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council

    Ivano-Frankivsk, 76008, Ukraine

  • Public Non-profit Enterprise of Lviv Regional Council Lviv Public non profit Regional Clinical Hospital

    Lviv, 79010, Ukraine

  • SBU Adana City Education and Research Hospital

    Adana, 01370, Turkey (Türkiye)

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Łęcznej

    Łęczna, 21-010, Poland

  • San Raffaele Hospital

    Milan, 20132, Italy

  • Southampton General Hospital

    Southampton, SO16 SYD, United Kingdom

  • St. Mary's Medical Center

    West Palm Beach, Florida, 33407, United States

  • Tbilisi Institute of Medicine

    Tbilisi, 00160, Georgia

  • The University of Florida

    Gainesville, Florida, 32610, United States

  • Univeristy Clinical Hospital Mostar

    Mostar, 88000, Bosnia and Herzegovina

  • Universitaetsklinikum Aachen, Klinik fuer Anaesthesiologie

    Aachen, 52074, Germany

  • Universitaetsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin-Hufelandstraße

    Essen, D-45147, Germany

  • Universitaetsklinikum Frankfurt - Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie

    Frankfurt am Main, 60590, Germany

  • Universitatsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitatsklinikum Tubingen Hertie-lnstitut fur klinische Hirnforschung (HIH) / Neurologische Universitatsklinik

    Tübingen, Germany, Germany

  • University Clinical Center Tuzla

    Tuzla, 75000, Bosnia and Herzegovina

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000, Bosnia and Herzegovina

  • University Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • İnönü University Faculty of Medicine

    Battalgazi, 44280, Turkey (Türkiye)