Low Dose Heparin Factorial Trial

NCT05591872 | Unknown Phase 3 FDA Drug

• 1 other identifier: THI-INNOSEAL3-2022
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

radial artery occlusion, left heart catheterization, heparin, hemostatic patch

Outcome Measures

Primary Outcomes (1)

• Compression time

  Time from radial sheath removal to the time of TRB removal

  45 minutes

Secondary Outcomes (2)

• radial artery occlusion

  24 hours

• Hematoma at the access site

  24 hours

Study Arms (4)

LD+I+TRB

ACTIVE COMPARATOR

Patient will get heparin dose according to their weight i.e. (\<60 Kg-2000 IU; 60-80 Kg-2500 IU; \>80 Kg-3000 IU) And access site will be secured with InnoSEAL patch plus TRB

Drug: LD+I+TRB

LD+TRB

ACTIVE COMPARATOR

Patient will get heparin dose according to their weight i.e. (\<60 Kg-2000 IU; 60-80 Kg-2500 IU; \>80 Kg-3000 IU) And access site will be secured with TRB alone

Drug: LD+I+TRB

SD+I+TRB

ACTIVE COMPARATOR

Patient will get standard heparin dose of 5000 IU. And access site will be secured with InnoSEAL patch plus TRB

Drug: LD+I+TRB

SD+TRB

NO INTERVENTION

This is the control arm. Patient will get standard heparin dose of 5000 IU. And access site will be secured with TRB.

Interventions

LD+I+TRB DRUG

Same as in the arm description

Also known as: SD+I+TRB, LD+TRB

LD+I+TRB; LD+TRB; SD+I+TRB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tabba Heart Institute: lead
• InnoTherapy Inc: collaborator

Study Sites (1)

Sana

Karachi, Sindh, 75290, Pakistan

RECRUITING

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sana Sheikh, M.Sc

  Tabba Heart Institute

  STUDY DIRECTOR

Central Study Contacts

Sana Sheikh, M.Sc

CONTACT

+92-21-36811841; sana.sheikh@tabbaheart.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 Heparin: Low dose (LD) vs. standard dose (SD) Device type: InnoSEAL + TRBand (I+TRB) vs. TRBand alone (TRB) Intervention arms: 1. LD+I+TRB 2. LD+TRB 3. SD+I+TRB 4. SD+TRB

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: May 9, 2022
• Primary Completion: April 30, 2023
• Study Completion: October 31, 2023
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)