drugset / Trial / NCT05591872

Low Dose Heparin Factorial Trial

NCT05591872

Phase 3 Unknown 800 enrolled Tabba Heart Institute InnoTherapy Inc · collab
RandomizedFactorialOpen-labelPrevention

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).

Timeline

Start
2022-05-09
Primary completion
2023-04-30
Completion
2023-10-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Heparin Other / unclassified 2000 iu Intravenous
Comparator Heparin Other / unclassified 2500 iu Intravenous
Comparator Heparin Other / unclassified 3000 iu Intravenous
Comparator Heparin Other / unclassified 5000 iu Intravenous

Indications