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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05591872
Other study ID # THI-INNOSEAL3-2022
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 9, 2022
Est. completion date October 31, 2023

Study information

Verified date October 2022
Source Tabba Heart Institute
Contact Sana Sheikh, M.Sc
Phone +92-21-36811841
Email sana.sheikh@tabbaheart.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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the protocol, then at 10, 20, and 30 minutes after the procedure 2cc, then 4cc, and then 6cc or remaining air will be withdrawn.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


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LD+I+TRB
Same as in the arm description

Locations

Country Name City State
Pakistan Sana Karachi Sindh

Sponsors (2)

Lead Sponsor Collaborator
Tabba Heart Institute InnoTherapy Inc

Country where clinical trial is conducted

Pakistan, 

Outcome

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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