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NCT04867837

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

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Major Bleeding

Keywords

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Direct Oral Anticoagulant Factor Xa Inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Blinded

Study Groups

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Octaplex Low-dose

Participants to receive 1 Octaplex infusion intravenously

Group Type EXPERIMENTAL

Octaplex

Intervention Type DRUG

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

Octaplex High-dose

Participants to receive 1 Octaplex infusion intravenously

Group Type EXPERIMENTAL

Octaplex

Intervention Type DRUG

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

Interventions

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Octaplex

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

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United States Austria Bosnia and Herzegovina Croatia France Georgia Germany Italy Poland Spain Turkey (Türkiye) Ukraine United Kingdom

Central Contacts

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Sigurd Knaub, PhD

Role: CONTACT

Phone: +41554512141

Email: [email protected]

Other Identifiers

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LEX-210

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Octaplex Low-dose

Octaplex

Octaplex High-dose

Octaplex

Interventions

Octaplex

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Octapharma

Responsible Party

Locations

Harbor-UCLA Medical Center

The University of Florida

St. Mary's Medical Center

Beth Israel Deaconess Medical Center

Hennepin County Medical Center

University of Mississippi Medical Center

OU Health - University of Oklahoma Medical Center

Oregon Health & Science University

Ascension Seton Medical Center Austin

Dell Seton Medical Center at the University of Texas

Klinikum Klagenfurt am Wörthersee Anästhesiologie und Intensivmedizin

University Clinical Centre of the Republic of Srpska

Univeristy Clinical Hospital Mostar

Clinical Center University of Sarajevo

University Clinical Center Tuzla

Clinical Hospital Dubrava

University Hospital Centre Zagreb

Centre Hospitalier Universitaire Francois Mitterand

Pineo Medical Ecosystem

Tbilisi Institute of Medicine

LTS ,, Israel-Geoargian Medical Research clinic Helsicore"

New Hospitals

K.Eristavi National Center of Experimental and Clinical Surgery

Universitaetsklinikum Aachen, Klinik fuer Anaesthesiologie

Universitatsklinikum Erlangen

Universitaetsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin-Hufelandstraße

Universitaetsklinikum Frankfurt - Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie

Heidelberg University Hospital Neurologische Universitätsklinik

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

Ospedale Maggiore - IRCCS Istituto di Scienze Neurologiche di Bologna

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

San Raffaele Hospital

Azienda Ospedaliero -Universitaria di Modena

Ospedale Santa Maria della Misericordia

Azienda Ospedaliero-Universitaria Senese

Ośrodek Badań Klinicznych BD Research

Clinical Research Center at Special Hospital Stefan Zeromski

Military Institute of Medicine

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Łęcznej

Hospital Universitario La Paz

Hospital Universitario Ramón y Cajal

Hospital Universitario 12 de Octubre

Hospital Dr. Peset

Hospital Universitario y Politecnico La Fe

SBU Adana City Education and Research Hospital

Ankara University Faculty of Medicine

İnönü University Faculty of Medicine

Health Sciences University Bursa High Specialization Training and Research Hospital

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

Ege University Faculty of Medicine

Kahramanmaraş Sütçü İmam University Faculty of Medicine

Mersin University Faculty of Medicine

Ondokuz Mayıs University Faculty of Medicine

Karadeniz Technical University

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

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

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

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