Low Dose Heparin Factorial Trial

• Status: Recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

An open label 2x2 factorial randomized trial is planned to determine the difference in mean hemostasis time between low dose heparin (LD) i.e between 2000-3000 IU and standard dose heparin (SD) i.e. 5000 IU with or without catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc. S Korea) used in conjunction with TRB (InnoSEAL+TRB [I+TRB]) among patients who are undergoing left heart cath at Tabba Heart Institute.

Secondary objectives include testing the difference in radial artery occlusion (RAO), and hematoma (III, IV grade) and composite outcome (RAO+hematoma).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tabba Heart Institute
• Collaborator: InnoTherapy Inc

Criteria

Inclusion Criteria:

• Hemodynamically stable adult patients of both genders, who will undergo transradial coronary angiogram (CAG) using 6 F sheath will be included.

Exclusion Criteria:

• Patients who had STEMI, are on anticoagulants after procedure or on an ongoing anticoagulation therapy, have ipsilateral arteriovenous fistula, RAO at baseline, Barbeau's class D will be excluded.