Comparing fixed dosing versus individualized dosing of prothrombine complex concentrate in treating (possible) bleeding in users of vitamin K antagonists.

Fixed versus variable dosing strategy of prothrombin complex concentrate for bleeding complications of vitamin K antagonists - PROPER3

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000392-33-NL

Enrollment

480

Registered

2014-07-09

Start date

2015-06-30

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major bleeding complications of vitamin K antagonists MedDRA version: 17.0 Level: PT Classification code 10009678 Term: Clotting factor transfusion System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Cofact (Sanquin) Beriplex (CSL Behring) Octaplex (Octapharma) Pharmaceutical Form: Concentrate for solution for injection IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Indication for PCC, because of VKA related bleeding Age = 18 years 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 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240

Exclusion criteria

Exclusion criteria: Intracranial bleeding Indication for PCC not related to bleeding Indication for PCC not related to VKA Previous participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To test whether the clinical outcome, defined as haemostatic efficacy, of a lower fixed dose of PCC is non-inferior to the higher variable dose of PCC, for VKA related bleeding in a randomized setting.;Secondary Objective: To compare INR as a surrogate endpoint and other variables such as time to PCC administration, total PCC dose, thrombotic complications, length of hospital/ICU stay and mortality. ; Primary end point(s): Successful clinical outcome, defined as excellent or good haemostatic efficacy, assessed over 24 hours from start of infusion. ;Timepoint(s) of evaluation of this end point: 24 hours after start of PCC administration	—

Measure

Time frame

Main Objective: To test whether the clinical outcome, defined as haemostatic efficacy, of a lower fixed dose of PCC is non-inferior to the higher variable dose of PCC, for VKA related bleeding in a randomized setting.;Secondary Objective: To compare INR as a surrogate endpoint and other variables such as time to PCC administration, total PCC dose, thrombotic complications, length of hospital/ICU stay and mortality. ; Primary end point(s): Successful clinical outcome, defined as excellent or good haemostatic efficacy, assessed over 24 hours from start of infusion. ;Timepoint(s) of evaluation of this end point: 24 hours after start of PCC administration

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Secondary

Measure	Time frame
Secondary end point(s): - proportion of patients with excellent, good and poor/none haemostatic efficacy - INR 15-60 minutes after end of infusion of PCC - proportion of patients reaching INR = 2.0 15-60 min after end of infusion of PCC - time between admission to emergency room and start of infusion of PCC - repeated dosing of, total administered dose of PCC - in-hospital all-cause mortality - all-cause mortality at 30 days after initial PCC administration - thrombotic complications (venous thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke) during hospital stay and at 30 days - duration of hospital stay, number of days in ICU ;Timepoint(s) of evaluation of this end point: As specified in E5.2	—

Measure

Time frame

Secondary end point(s): - proportion of patients with excellent, good and poor/none haemostatic efficacy - INR 15-60 minutes after end of infusion of PCC - proportion of patients reaching INR = 2.0 15-60 min after end of infusion of PCC - time between admission to emergency room and start of infusion of PCC - repeated dosing of, total administered dose of PCC - in-hospital all-cause mortality - all-cause mortality at 30 days after initial PCC administration - thrombotic complications (venous thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke) during hospital stay and at 30 days - duration of hospital stay, number of days in ICU ;Timepoint(s) of evaluation of this end point: As specified in E5.2

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Countries

Netherlands

Contacts

Public ContactDepartment of Hematology

UMC Groningen

0031503616161

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 24, 2026