Clinical trial NCT05591872: Low Dose Heparin Factorial Trial
Official title: Low Dose Versus High Dose Heparin With or Without Hemostasis Patch and Radial Access Site Outcomes; an Open-label Factorial Randomized Trial (InnoSEAL III)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Radial Artery Occlusion
Keywords: radial artery occlusion, left heart catheterization, heparin, hemostatic patch
Lead sponsor: Tabba Heart Institute
Sponsor class: OTHER
Collaborators: name: InnoTherapy Inc
First posted: 2022-10-24
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Compression time
timeFrame: 45 minutes
Secondary outcomes:
measure: radial artery occlusion
timeFrame: 24 hours
measure: Hematoma at the access site
timeFrame: 24 hours
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sana
state: Sindh
Study officials:
affiliation: Tabba Heart Institute
name: Sana Sheikh, M.Sc
role: STUDY_DIRECTOR
References: