Rivaroxaban and PCC: Prothrombin Complex Concentrate (Beriplex®) in patients with bleeding complications related to Rivaroxaban (Xarelto®)

Phase 1

• Conditions: blood coagulation disorder; MedDRA version: 18.1Level: HLTClassification code 10009728Term: Coagulation and bleeding analysesSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-004484-31-AT
• Lead Sponsor: Medizinische Universität Innsbruck / Allg. u. chirug. Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-13
• Study Completion: 2016-10-21
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

I.1.Patient at the obvious age of = 18 years of either sex
I.2. Patients receiving Rivaroxaban
I.3.aPatients with significant bleeding with the need of reversal
AND/OR
I.3.bPatients needing acute reversal of rivaroxaban anticoagulation effects

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

E.1. Additional treatment with further procoagulant therapy including recombinant activated factor seven, FEIBA or other coagulation factor concentrates (except fibrinogen concentrate, DDAVP and tranexamic acid)
E.2.Risk for thromboembolic events higher than the bleeding risk as anticipated by the physician
E.3.Pregnant or nursing women
for emergency patients: obviously pregnant women
E.4.Patient with suspected or confirmed sepsis
E.5.Patient with known recent history of thromboembolic events within the last 3 months
E.6. Patients who disagree to participate in the study
for emergency patients: patients with known refusal of a participation in this clinical trial
E.7.Known active participation in a clinical trial
E.8.Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she would participate in the study or confound in the ability to interpret data from the study
E.9.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of effective reversal of Rivaroxaban (Xarelto) with Prothrombin Complex Concentrate (Beriplex);Secondary Objective: Assessment of the differences in the response profile of the following parameters:<br>- Coagulation status <br>- Coagulation factor profile <br>- Standard coagulation tests <br>- Functional coagulation tests <br>- Inflammation profile<br>- Other biological and clinical parameters <br>- differences between groups<br>;Primary end point(s): Difference in the thrombin generation between t1 and t2;Timepoint(s) of evaluation of this end point: between t1 and t2

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Developing of following parameters from V1 to V10 in correlation with blood level of Rivaroxaban (Xarelto®) and thrombin generation:<br>- Thrombin generation <br>- Single factor profiles <br>- Standard coagulation tests outcome (PT, aPTT, fibrinogen, AT, etc.)<br>- ROTEM® results (FibTEM, ExTEM, InTEM, HepTEM)<br>- Further biological parameters<br>- Differences between sample groups <br>;Timepoint(s) of evaluation of this end point: from V1 to V10