Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Major Bleeding Acute major bleeding in patients receiving DOAC therapy with factor Xa inhibitor

Keywords

Direct Oral AnticoagulantFactor Xa Inhibitor

Outcome Measures

Primary Outcomes (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
Within 24 hours after the start of initial management

Secondary Outcomes (7)

Change in endogenous thrombin potential (ETP)
From baseline to 1 hour after administration of drug
All-cause TEEs and All-cause Mortality
30 days
Occurrence of Adverse Events (AEs)
From IMP infusion until Day 30
Body Temperature
From day of IMP infusion until Day 30
Pulse
From day of IMP infusion until Day 30
+2 more secondary outcomes

Other Outcomes (13)

Change in Hgb
48 hours after administration of drug
Change in haematocrit (Hct)
48 hours after administration of drug
Change in red blood cell (RBC) levels
48 hours after administration of drug
+10 more other outcomes

Study Arms (2)

Octaplex Low-dose

EXPERIMENTAL

Participants to receive 1 Octaplex infusion intravenously

Drug: Octaplex

Octaplex High-dose

EXPERIMENTAL

Participants to receive 1 Octaplex infusion intravenously

Drug: Octaplex

Interventions

OctaplexDrug

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

Octaplex High-doseOctaplex Low-dose

Octaplex 500 I.E. Pulver und Lösungsmittel zur Herstellung einer InfusionslösungType not reported

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Octapharma
Industrylead
Octapharma AG
Industrylead

Study Sites (63)

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

The University of Florida

Gainesville, Florida, 32610, United States

St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

OU Health - University of Oklahoma Medical Center

MeSH Terms

Interventions

prothrombin complex concentrates

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Masking Details: Blinded
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 30, 2021

Study Start

September 1, 2021

Actual (reported)

You may not qualify if:

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
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
+1 more criteria

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Other Outcomes (13)

Study Arms (2)

Octaplex Low-dose

Octaplex High-dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (63)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Other Outcomes (13)

Study Arms (2)

Octaplex Low-dose

Octaplex High-dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (63)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations