Actively Recruiting
Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
Led by Octapharma · Updated on 2025-11-12
260
Participants Needed
63
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients on oral factor Xa inhibitor therapy with known or suspected baseline anti-factor Xa activity of at least 100 ng/mL, or believed to have received their latest dose of oral factor Xa inhibitor within 8 hours prior to enrollment, or with suspected baseline anti-factor Xa activity of at least 100 ng/mL and clinical indication for OCTAPLEX
- Aged 18 years or older
- Patients who have given written informed consent, or consent obtained from legally authorized representative if patient is incapable
- Patients with acute major bleeding that is life-threatening, uncontrolled, symptomatic in critical organs, or causing a significant drop in hemoglobin level
You will not qualify if you...
- Patients with 'Do not resuscitate' (DNR) orders
- Patients with acute trauma where reversal of DOAC therapy alone would not control bleeding
- Hemoglobin decrease without evidence of bleeding source
- Acute coronary syndrome, ischemic stroke, or venous thromboembolism within the last 3 months
- History of disseminated intravascular coagulation or hyperfibrinolysis within the last 3 months
- Known congenital bleeding disorders
- Known inhibitors to coagulation factors II, VII, IX, or X; heparin-induced type II thrombocytopenia; or IgA deficiency with antibodies
- Known hypersensitivity to plasma-derived products or heparin
- Receipt of certain hemostatic agents for current bleeding before enrollment
- Recent use of specific antiplatelet drugs before bleeding event
- Use of enoxaparin for thromboembolic prophylaxis
- Glasgow Coma Scale score less than 7 in non-intubated patients or large intracerebral hematoma volume
- Expected survival less than 24 hours
- Scheduled surgery within 12 hours except minor or diagnostic/therapeutic procedures
- Pregnancy or breastfeeding at enrollment
- Previous enrollment in this study
- Participation in another interventional treatment study currently or within past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 63 locations
1
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
Terminated
2
The University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
3
St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Terminated
5
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Terminated
6
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Terminated
7
OU Health - University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States, 73104
Terminated
8
Oregon Health & Science University
Portland, Oregon, United States, 97239
Terminated
9
Ascension Seton Medical Center Austin
Austin, Texas, United States, 78712
Terminated
10
Dell Seton Medical Center at the University of Texas
Austin, Texas, United States, 78712
Terminated
11
Klinikum Klagenfurt am Wörthersee Anästhesiologie und Intensivmedizin
Klagenfurt, Austria, 9020
Terminated
12
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina, 78000
Terminated
13
Univeristy Clinical Hospital Mostar
Mostar, Bosnia and Herzegovina, 88000
Terminated
14
Clinical Center University of Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
Active, Not Recruiting
15
University Clinical Center Tuzla
Tuzla, Bosnia and Herzegovina, 75000
Active, Not Recruiting
16
Clinical Hospital Dubrava
Zagreb, Croatia, 10000
Terminated
17
University Hospital Centre Zagreb
Zagreb, Croatia, 10000
Terminated
18
Centre Hospitalier Universitaire Francois Mitterand
Dijon, France, 21000
Terminated
19
Pineo Medical Ecosystem
Tbilisi, Georgia, 00108
Actively Recruiting
20
Tbilisi Institute of Medicine
Tbilisi, Georgia, 00160
Actively Recruiting
21
LTS ,, Israel-Geoargian Medical Research clinic Helsicore"
Tbilisi, Georgia, 112
Actively Recruiting
22
New Hospitals
Tbilisi, Georgia, 114
Actively Recruiting
23
K.Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia, 159
Actively Recruiting
24
Universitaetsklinikum Aachen, Klinik fuer Anaesthesiologie
Aachen, Germany, 52074
Active, Not Recruiting
25
Universitatsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
26
Universitaetsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin-Hufelandstraße
Essen, Germany, D-45147
Actively Recruiting
27
Universitaetsklinikum Frankfurt - Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie
Frankfurt am Main, Germany, 60590
Actively Recruiting
28
Heidelberg University Hospital Neurologische Universitätsklinik
Heidelberg, Germany, 69120
Actively Recruiting
29
Universitatsklinikum Tubingen Hertie-lnstitut fur klinische Hirnforschung (HIH) / Neurologische Universitatsklinik
Tübingen, Germany, Germany
Actively Recruiting
30
Ospedale Maggiore - IRCCS Istituto di Scienze Neurologiche di Bologna
Bologna, Italy, 40133
Actively Recruiting
31
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Terminated
32
San Raffaele Hospital
Milan, Italy, 20132
Terminated
33
Azienda Ospedaliero -Universitaria di Modena
Modena, Italy, 41125
Active, Not Recruiting
34
Ospedale Santa Maria della Misericordia
Perugia, Italy, 06156
Actively Recruiting
35
Azienda Ospedaliero-Universitaria Senese
Siena, Italy, 53100
Active, Not Recruiting
36
Ośrodek Badań Klinicznych BD Research
Iława, Poland, 14-200
Actively Recruiting
37
Clinical Research Center at Special Hospital Stefan Zeromski
Krakow, Poland, 31-913
Actively Recruiting
38
Military Institute of Medicine
Warsaw, Poland, 04-141
Terminated
39
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Łęcznej
Łęczna, Poland, 21-010
Actively Recruiting
40
Hospital Universitario La Paz
Madrid, Spain, 00261
Actively Recruiting
41
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
42
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
43
Hospital Dr. Peset
Valencia, Spain, 46017
Active, Not Recruiting
44
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
45
SBU Adana City Education and Research Hospital
Adana, Turkey (Türkiye), 01370
Actively Recruiting
46
Ankara University Faculty of Medicine
Ankara, Turkey (Türkiye), 6230
Actively Recruiting
47
İnönü University Faculty of Medicine
Battalgazi, Turkey (Türkiye), 44280
Actively Recruiting
48
Health Sciences University Bursa High Specialization Training and Research Hospital
Bursa, Turkey (Türkiye), 16300
Actively Recruiting
49
Istanbul University Istanbul Faculty of Medicine Department of Internal Diseases, Division of Hematology
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
50
Ege University Faculty of Medicine
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
51
Kahramanmaraş Sütçü İmam University Faculty of Medicine
Kahramanmaraş, Turkey (Türkiye), 46040
Actively Recruiting
52
Mersin University Faculty of Medicine
Mersin, Turkey (Türkiye), 33343
Actively Recruiting
53
Ondokuz Mayıs University Faculty of Medicine
Samsun, Turkey (Türkiye), 55280
Actively Recruiting
54
Karadeniz Technical University
Trabzon, Turkey (Türkiye), 61080
Actively Recruiting
55
Public Non-profit Enterprise Clinical Emergency Care Hospital of Dnipro City Counsil
Dnipro, Ukraine, 49006
Actively Recruiting
56
Public Non-profit Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council
Ivano-Frankivsk, Ukraine, 76008
Active, Not Recruiting
57
Public Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council
Ivano-Frankivsk, Ukraine, 76025
Active, Not Recruiting
58
Medical and Diagnostic Center of Private Enterprise of Private Manufacturing Company "Acinus"
Kropyvnytskyi, Ukraine, 26006
Actively Recruiting
59
Public Non-profit Enterprise Kyiv City Clinical Hospital #17 of Kyiv City Council Executive Body
Kyiv, Ukraine, 01133
Not Yet Recruiting
60
Public Non-profit Enterprise of Lviv Regional Council Lviv Public non profit Regional Clinical Hospital
Lviv, Ukraine, 79010
Actively Recruiting
61
North Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Terminated
62
Nottingham University Hospital
Nottingham, United Kingdom, NG51PB
Terminated
63
Southampton General Hospital
Southampton, United Kingdom, SO16 SYD
Terminated
Research Team
S
Sigurd Knaub, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here