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Acute Major BleedingPhase 3NCT04867837

Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

A Phase 3 study testing Octaplex in people with Acute Major Bleeding, run by Octapharma at 63 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Major Bleeding
What is being tested?
Octaplex
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
63 sitesin 13 countries
Study dates
1 Sep 2021to 13 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • Aged ≥18 years
  • 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
  • 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

Who cannot join

  • Patients with 'Do not resuscitate' (DNR) orders
  • Patients with acute trauma for which reversal of DOAC therapy with factor Xa inhibitor alone would not be expected to control the bleeding event
  • Hgb decrease without accompanying evidence of source of bleeding
  • Acute coronary syndrome, ischaemic stroke or venous thromboembolism (VTE) within the preceding 3 months
  • Patients with a history, within the last 3 months, of disseminated intravascular coagulation (DIC) or hyperfibrinolysis
  • Patients with a known congenital bleeding disorder
Show all 17Show fewer
  • 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
  • Known hypersensitivity to plasma-derived products or heparin
  • 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)
  • 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
  • Patients on enoxaparin therapy for thromboembolic prophylaxis
  • 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)
  • 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)
  • 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
  • Patients who are pregnant or breastfeeding at the time of enrollment
  • Patients previously enrolled in this study
  • Patients participating in another interventional clinical treatment study currently or during the past 1 month prior to study inclusion

Trial locations and contacts

63 sites in 13 countries.

63 sites in 13 countries

United States10 sites

  • Ascension Seton Medical Center Austin

    Austin, Texas, 78712

  • Dell Seton Medical Center at the University of Texas

    Austin, Texas, 78712

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The University of Florida

    Gainesville, Florida, 32610

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • OU Health - University of Oklahoma Medical Center

    Oklahoma City, Oklahoma, 73104

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Harbor-UCLA Medical Center

    Torrance, California, 90509

  • St. Mary's Medical Center

    West Palm Beach, Florida, 33407

Other trials in United States

Turkey (Türkiye)10 sites

  • SBU Adana City Education and Research Hospital

    Adana, 01370

  • Ankara University Faculty of Medicine

    Ankara, 6230

  • İnönü University Faculty of Medicine

    Battalgazi, 44280

  • Health Sciences University Bursa High Specialization Training and Research Hospital

    Bursa, 16300

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

    Istanbul, 34093

  • Ege University Faculty of Medicine

    Izmir, 35100

  • Kahramanmaraş Sütçü İmam University Faculty of Medicine

    Kahramanmaraş, 46040

  • Mersin University Faculty of Medicine

    Mersin, 33343

  • Ondokuz Mayıs University Faculty of Medicine

    Samsun, 55280

  • Karadeniz Technical University

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Germany6 sites

  • Universitaetsklinikum Aachen, Klinik fuer Anaesthesiologie

    Aachen, 52074

  • Universitatsklinikum Erlangen

    Erlangen, 91054

  • Universitaetsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin-Hufelandstraße

    Essen, D-45147

  • Universitaetsklinikum Frankfurt - Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie

    Frankfurt am Main, 60590

  • Heidelberg University Hospital Neurologische Universitätsklinik

    Heidelberg, 69120

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

    Tübingen, Germany

Other trials in Germany

Italy6 sites

  • Ospedale Maggiore - IRCCS Istituto di Scienze Neurologiche di Bologna

    Bologna, 40133

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • San Raffaele Hospital

    Milan, 20132

  • Azienda Ospedaliero -Universitaria di Modena

    Modena, 41125

  • Ospedale Santa Maria della Misericordia

    Perugia, 06156

  • Azienda Ospedaliero-Universitaria Senese

    Siena, 53100

Other trials in Italy

Ukraine6 sites

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

    Dnipro, 49006

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

    Ivano-Frankivsk, 76008

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

    Ivano-Frankivsk, 76025

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

    Kropyvnytskyi, 26006

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

    Kyiv, 01133

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

    Lviv, 79010

Other trials in Ukraine

Georgia5 sites

  • Pineo Medical Ecosystem

    Tbilisi, 00108

  • Tbilisi Institute of Medicine

    Tbilisi, 00160

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

    Tbilisi, 112

  • New Hospitals

    Tbilisi, 114

  • K.Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 159

Other trials in Georgia

Spain5 sites

  • Hospital Universitario La Paz

    Madrid, 00261

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Dr. Peset

    Valencia, 46017

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026

Other trials in Spain

Bosnia and Herzegovina4 sites

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000

  • Univeristy Clinical Hospital Mostar

    Mostar, 88000

  • Clinical Center University of Sarajevo

    Sarajevo, 71000

  • University Clinical Center Tuzla

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Poland4 sites

  • Ośrodek Badań Klinicznych BD Research

    Iława, 14-200

  • Clinical Research Center at Special Hospital Stefan Zeromski

    Krakow, 31-913

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Łęcznej

    Łęczna, 21-010

  • Military Institute of Medicine

    Warsaw, 04-141

Other trials in Poland

United Kingdom3 sites

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

    Basingstoke, Hampshire, RG24 9NA

  • Nottingham University Hospital

    Nottingham, NG51PB

  • Southampton General Hospital

    Southampton, SO16 SYD

Other trials in United Kingdom

Croatia2 sites

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • University Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Austria1 site

  • Klinikum Klagenfurt am Wörthersee Anästhesiologie und Intensivmedizin

    Klagenfurt, 9020

Other trials in Austria

France1 site

  • Centre Hospitalier Universitaire Francois Mitterand

    Dijon, 21000

Other trials in France

About this study

Official title: Study of Four-factor Prothrombin Complex Concentrate, OCTAPLEX, in Patients With Acute Major Bleeding on Direct Oral Anticoagulant (DOAC) Therapy With Factor Xa Inhibitor

This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.

Being tested
Octaplex
Keywords
Direct Oral Anticoagulant, Factor Xa Inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OctaplexDrug

    Four-factor prothrombin complex concentrate (4F-PCC)

Study groups in NCT04867837
Study groupRoleWhat they receive
Octaplex Low-doseExperimentalParticipants to receive 1 Octaplex infusion intravenously
Receives: Drug: Octaplex
Octaplex High-doseExperimentalParticipants to receive 1 Octaplex infusion intravenously
Receives: Drug: Octaplex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemostatic efficacy

    Binary outcome of effective (rating of excellent or good) or non-effective (rating of poor/none) in management of major bleeding events as assessed by the Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC) according to predefined criteria

    Measured: Within 24 hours after the start of initial management

Secondary outcomes (7)

  1. Change in endogenous thrombin potential (ETP)

    Change in ETP as measured by thrombin generation assay

    Measured: From baseline to 1 hour after administration of drug

  2. All-cause TEEs and All-cause Mortality

    30-day event rate of thromboembolic events (TEEs) and all-cause mortality

    Measured: 30 days

  3. Occurrence of Adverse Events (AEs)

    Occurrence of any AEs from start of OCTAPLEX administration until end of study

    Measured: From IMP infusion until Day 30

  4. Body Temperature

    Temperature measured during a 48-hour follow-up period after OCTAPLEX administration and at discharge

    Measured: From day of IMP infusion until Day 30

  5. Pulse

    Pulse during a 48-hour follow-up period after OCTAPLEX administration and at discharge

    Measured: From day of IMP infusion until Day 30

  6. Respiration rate

    Respiration rate during a 48-hour follow-up period after OCTAPLEX administration and at discharge

    Measured: From day of IMP infusion until Day 30

  7. Blood pressure

    Blood pressure during a 48-hour follow-up period after OCTAPLEX administration and at discharge

    Measured: From day of IMP infusion until Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start1 Sep 2021
  3. Primary completion13 Jan 2026
  4. Study completion13 Jan 2026

Why it stopped: Following Interim Analysis IDMEAC concluded:1-No safety concerns 2-Suspend enrolment: Futility based on treatment effect size at interim analysis. Enrollment was suspended on 22DEC25. Study was terminated FEB2026. Final analysis is planned in Q2 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04867837
Sponsor's protocol ID
LEX-210
Status last verified
Jun 2026
First submitted
19 Apr 2021
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Octaplex in people with Acute Major Bleeding, run by Octapharma at 63 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Turkey (Türkiye), Germany, Italy, Ukraine and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Following Interim Analysis IDMEAC concluded:1-No safety concerns 2-Suspend enrolment: Futility based on treatment effect size at interim analysis. Enrollment was suspended on 22DEC25. Study was terminated FEB2026. Final analysis is planned in Q2 2026). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemostatic efficacy (time frame: Within 24 hours after the start of initial management). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04867837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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