Low Dose Heparin Factorial Trial

NCT ID: NCT05591872

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2023-10-31

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).

Detailed Description

Eligibility criteria:

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

Intervention:

After written consent, first randomization will be done to the heparin arm. If participant falls in LD heparin group, he/she will receive IV heparin 2000-3000 IU (<60 Kg-2000 IU; 60-80 Kg-2500 IU; >80 Kg-3000 IU) at the start of CAG and if SD then 5000 IU of heparin will be administered. Second randomization will be done to allocate the participant in I+TRB or TRB alone arm.

In I+TRB arm, after the completion of CAG, at radial artery site, the sheath is pulled 2-3cm and the area surrounding the puncture site is cleaned, dried and InnoSEAL is placed over the puncture site. A transparent adhesive clear dressing is placed over the InnoSEAL and TRB is applied over the dressing.

In TRB arm, TRB alone will be applied over the puncture site. In both the arms, 10 cc air will be inserted in TRB at the start of the protocol, then at 10, 20, and 30 minutes after the procedure 2cc, then 4cc, and then 6cc or remaining air will be withdrawn. If patient oozes or bleeds from radial site in between the protocol, 2 cc air or more will be inserted to control the bleeding. After reaching 0cc air in TRB, deflated TRB will be observed for 15 minutes. The TRB will be removed and access site will further be observed for 15 minutes for hematoma, oozing/bleeding.

At each air draw, reverse Barbeau's test will be done to check the radial artery occlusion. If radial pulse is found absent after removing TRB, then radial artery colored doppler ultrasound will be done to confirm the radial artery occlusion.

The time from the removal of radial sheath till removal of TRB will be recorded as the compression time needed to achieve hemostasis at the radial access site.

Conditions

Radial Artery Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

LD+I+TRB

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

Group Type: ACTIVE_COMPARATOR

LD+I+TRB

Intervention Type: DRUG

Same as in the arm description

LD+TRB

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

Group Type: ACTIVE_COMPARATOR

LD+I+TRB

Intervention Type: DRUG

Same as in the arm description

SD+I+TRB

Patient will get standard heparin dose of 5000 IU.

And access site will be secured with InnoSEAL patch plus TRB

Group Type: ACTIVE_COMPARATOR

LD+I+TRB

Intervention Type: DRUG

Same as in the arm description

SD+TRB

This is the control arm. Patient will get standard heparin dose of 5000 IU.

And access site will be secured with TRB.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LD+I+TRB

Same as in the arm description

Intervention Type: DRUG

Other Intervention Names

SD+I+TRB; LD+TRB

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InnoTherapy Inc

UNKNOWN

Sponsor Role: collaborator

Tabba Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sana Sheikh, M.Sc

Role: STUDY_DIRECTOR

Tabba Heart Institute

Locations

Sana

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Sana Sheikh, M.Sc

Role: CONTACT

sana.sheikh@tabbaheart.org

+92-21-36811841 ext. 1372

Facility Contacts

Sana Dr Sheikh, M. Sc

Role: primary

Other Identifiers

THI-INNOSEAL3-2022

Identifier Type: -

Identifier Source: org_study_id