Testing of reversal of anticoagulants in a patient model of controled arterial bleeding

Developing a Patient Model of Controlled, Radial Artery Access Site Bleeding for Deciding on Anticoagulation Reversal in Patients Treated by Systemic Anticoagulants.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005410-19-BE

Enrollment

Registered

2013-02-06

Start date

2013-03-11

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

With the novel oral anticoagulants, including EDOXABAN-DABIGATRANRIVAROXABAN- APIXABAN, we are entering a new era of anticoagulation for atrial fibrillation (AF) (and deep vein thrombosis). Nevertheless, at the time, the lack of a reversal agent is an important limitation with these agents, especially in case of major hemorrhage or the need to perform emergency invasive procedures. MedDRA version: 15.1 Level: PT Classification code 10060319 Term: Anticoagulation drug level therapeutic Syst

Interventions

Trade Name: Protamine sulphate Product Name: protamine sulfate Product Code: - Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Injection Route of administration of the p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject is eligible for diagnostic angiography via radial route for suspected coronary artery disease ('stable patients & lesions'). 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

Exclusion criteria: 1) An unfavourable angiographic morphology: a. Left main coronary artery stenosis >50% by visual estimate. b. Angiographic flow limiting complication (including visible thrombus) 2) Pre-treatement with a P2Y12 receptor blocker. 3) A known coagulopathy or bleeding diathesis

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial addresses the potential of intravenous protamine to reverse the anticoagulant effect of heparin and: Obtain improved local haemostasis after radial arterial sheet (5french) removal in stable cardiac patients undergoing a diagnostic coronary angiogram ('bleeding time').;Secondary Objective: Measurements of standard laboratory markers of anticoagulation will be used as evidence of reversal;Primary end point(s): The primary efficacy end point is the time to hemostasis at the radial artery puncture site after arterial sheath removal (dichotomized per 15 minutes).;Timepoint(s) of evaluation of this end point: 4 timepoints 15-30-60 minutes and 6 hours post randomization	—

Measure

Time frame

Main Objective: The primary objective of this trial addresses the potential of intravenous protamine to reverse the anticoagulant effect of heparin and: Obtain improved local haemostasis after radial arterial sheet (5french) removal in stable cardiac patients undergoing a diagnostic coronary angiogram ('bleeding time').;Secondary Objective: Measurements of standard laboratory markers of anticoagulation will be used as evidence of reversal;Primary end point(s): The primary efficacy end point is the time to hemostasis at the radial artery puncture site after arterial sheath removal (dichotomized per 15 minutes).;Timepoint(s) of evaluation of this end point: 4 timepoints 15-30-60 minutes and 6 hours post randomization

—

Secondary

Measure	Time frame
Secondary end point(s): Laboratory evidence of reversal of systemic anticoagulation expressed by measurements of standard laboratory markers [6* (2*4,5ml)= 54ml citrated blood].;Timepoint(s) of evaluation of this end point: 4 timepoints 15-30-60 minutes and 6 hours post randomization	—

Countries

Belgium

Contacts

Public ContactPI

Jessa ziekenhuis

pascal.vranckx@skynet.be3211309589

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026