Octaplex

DRUG3 trials

Sponsors

Octapharma

Conditions

Acute Major BleedingBleeding Cardiac Surgery PatientsSignificant Bleeding Risk

Phase 3

Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

CompletedNCT02740335

OctapharmaSignificant Bleeding Risk

Start: 2017-06-08End: 2022-02-23Updated: 2023-03-08

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

TerminatedNCT04867837

OctapharmaAcute Major Bleeding

Start: 2021-09-01End: 2026-01-13Updated: 2026-06-25

Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery

CompletedNCT05523297

OctapharmaBleeding Cardiac Surgery Patients

Start: 2022-11-30End: 2024-06-27Updated: 2025-08-15

Related Papers

The association of estimated citrate load with frozen plasma versus four-factor prothrombin complex concentrate for coagulopathy after cardiac surgery: a post hoc exploratory analysis of the FARES-II randomised controlled trial

BJA Open2026-06-29

Prothrombin complex concentrate in managing direct oral anticoagulant (DOAC)-associated bleeding and real-world use in vitamin k antagonist (VKA)-associated bleeding: The ongoing lex-210 and lex-212 studies

Blood2025-11-03

Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery: The FARES-II Multicenter Randomized Clinical Trial.

2025-05-0118 citations

Protocol for a phase 3, randomised, active-control study of four-factor prothrombin complex concentrate versus frozen plasma in bleeding adult cardiac surgery patients requiring coagulation factor replacement: the LEX-211 (FARES-II) trial

BMJ Open2024-08-017 citations

Vitamin K Antagonist Reversal for Urgent Surgery Using 4-Factor Prothrombin Complex Concentrates

JAMA Network Open2024-08-015 citations

Delayed cold-stored vs. room temperature stored platelet transfusions in bleeding adult cardiac surgery patients-a randomized multicentre pilot study (PLTS-1).

2024-06-152 citations

Updated Protocol for the Phase 3, Randomized, Double-Blinded Lex-210 Study of Four-Factor Prothrombin Complex Concentrate in Patients with Acute Major Bleeding on Factor Xa Inhibitor Therapy

Blood2023-11-021 citations

Randomized, Active-Control Phase 3 Study of Four-Factor Prothrombin Complex Concentrate Versus Frozen Plasma in Bleeding Adult Cardiac Surgery Patients

Blood2023-11-02

A Phase 3, Randomized, Double-Blinded Study of Four-Factor Prothrombin Complex Concentrate in Patients with Acute Major Bleeding on Direct Oral Anticoagulant Therapy with Factor Xa Inhibitor: The Lex-210 Study

Blood2021-11-051 citations