Low Dose Heparin Factorial Trial

Low Dose Versus High Dose Heparin With or Without Hemostasis Patch and Radial Access Site Outcomes; an Open-label Factorial Randomized Trial (InnoSEAL III)

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).

Study Overview

• Status: Recruiting
• Conditions: Radial Artery Occlusion
• Intervention / Treatment: Drug: LD+I+TRB

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the protocol, then at 10, 20, and 30 minutes after the procedure 2cc, then 4cc, and then 6cc or remaining air will be withdrawn.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.

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sana Sheikh, M.Sc; Phone Number: 1372 +92-21-36811841; Email: sana.sheikh@tabbaheart.org

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75290
      • Recruiting
      • Sana
      • Contact: Sana Dr Sheikh, M. Sc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Drug: LD+I+TRB; Same as in the arm description; Other Names: SD+I+TRB; LD+TRB
ACTIVE_COMPARATOR: 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	Drug: LD+I+TRB; Same as in the arm description; Other Names: SD+I+TRB; LD+TRB
ACTIVE_COMPARATOR: SD+I+TRB; Patient will get standard heparin dose of 5000 IU. And access site will be secured with InnoSEAL patch plus TRB	Drug: LD+I+TRB; Same as in the arm description; Other Names: SD+I+TRB; LD+TRB
NO_INTERVENTION: SD+TRB; This is the control arm. Patient will get standard heparin dose of 5000 IU. And access site will be secured with TRB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compression time	Time from radial sheath removal to the time of TRB removal	45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radial artery occlusion	Radial artery occlusion on colored doppler ultrasound	24 hours
Hematoma at the access site	Hematoma will be graded according to BRAC and BRAC III or IV will be considered as significant hematoma.	24 hours

Collaborators and Investigators

• Sponsor: Tabba Heart Institute
• Collaborators: InnoTherapy Inc
• Investigators: Study Director: Sana Sheikh, M.Sc, Tabba Heart Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2022
• Primary Completion (ANTICIPATED): April 30, 2023
• Study Completion (ANTICIPATED): October 31, 2023

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (ACTUAL): October 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: radial artery occlusion, left heart catheterization, heparin, hemostatic patch
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: THI-INNOSEAL3-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes