Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor

About this Study

The purpose of this study is to demonstrate how well OCTAPLEX works at different doses in people who have acute major bleeding and are currently taking medication which make their blood thinner.

Sponsor Protocol ID:LEX-210
IRB Number:2021V0540
Actively Enrolling
Interventional
Phase 3
March 31, 2022
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria
  • Patients who received a dose of factor Xa inhibitor
  • 18 years of age or greater
  • Patients who have acute major bleeding (bleeding that is potentially life threatening¬† or uncontrolled OR symptomatic bleeding in critical organ)

Exclusion Criteria
  • Patients with bleeding that is immediately life threatening
  • Patients with 'Do not resuscitate (DNR) orders
  • Decrease hemoglobin without accompanying evidence of source of bleeding
  • Acute coronary syndrome, ischaemic stroke or venous thromboembolism (VTE) within 3 months
  • Patients with known congenital coagulation disorder
  • Patients on enoxaparin therapy for thromboembolic prophylaxis
  • Patients with expected survival of less than 3 days
  • Patients who are pregnant or breastfeeding
  • Patient previously enrolled in this study
  • Patients participating in another interventional clinical study currently or during the last 1 month prior to screening for study

Categories Click category to view its trials.
Stroke/Traumatic Brain Injury
Participating Locations
Emergency Room (Adult) - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Tamara Brocks
Phone Number: 601-496-7811
Email: tbrocks2@umc.edu
Principal Investigator:Nandi, Utsav, M.D.
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