Radial Artery Occlusion Clinical 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)
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).
Status | Recruiting |
Enrollment | 800 |
Est. completion date | October 31, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Sana | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Tabba Heart Institute | InnoTherapy Inc |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compression time | Time from radial sheath removal to the time of TRB removal | 45 minutes | |
Secondary | radial artery occlusion | Radial artery occlusion on colored doppler ultrasound | 24 hours | |
Secondary | 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 |
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