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Low Dose Heparin Factorial Trial

NCT05591872 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2022-10-24

No results posted yet for this study

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).

Conditions

  • Radial Artery Occlusion

Interventions

DRUG

LD+I+TRB

Same as in the arm description

Sponsors & Collaborators

  • InnoTherapy Inc

    collaborator UNKNOWN

  • Tabba Heart Institute

    lead OTHER

Principal Investigators

  • Sana Sheikh, M.Sc · Tabba Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2023-04-30
Completion
2023-10-31
FDA Drug
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591872 on ClinicalTrials.gov