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Low Dose Heparin Factorial Trial

Primary Purpose

Radial Artery Occlusion

Status
Recruiting
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
LD+I+TRB
Sponsored by
Tabba Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radial Artery Occlusion focused on measuring radial artery occlusion, left heart catheterization, heparin, hemostatic patch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

LD+I+TRB

LD+TRB

SD+I+TRB

SD+TRB

Arm Description

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

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

Patient will get standard heparin dose of 5000 IU. And access site will be secured with InnoSEAL patch plus TRB

This is the control arm. Patient will get standard heparin dose of 5000 IU. And access site will be secured with TRB.

Outcomes

Primary Outcome Measures

Compression time
Time from radial sheath removal to the time of TRB removal

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2022
Last Updated
October 19, 2022
Sponsor
Tabba Heart Institute
Collaborators
InnoTherapy Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05591872
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tabba Heart Institute
Collaborators
InnoTherapy Inc

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Artery Occlusion
Keywords
radial artery occlusion, left heart catheterization, heparin, hemostatic patch

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Model Description
2x2 Heparin: Low dose (LD) vs. standard dose (SD) Device type: InnoSEAL + TRBand (I+TRB) vs. TRBand alone (TRB) Intervention arms: LD+I+TRB LD+TRB SD+I+TRB SD+TRB
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LD+I+TRB
Arm Type
Active Comparator
Arm Description
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
Arm Title
LD+TRB
Arm Type
Active Comparator
Arm Description
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
Arm Title
SD+I+TRB
Arm Type
Active Comparator
Arm Description
Patient will get standard heparin dose of 5000 IU. And access site will be secured with InnoSEAL patch plus TRB
Arm Title
SD+TRB
Arm Type
No Intervention
Arm Description
This is the control arm. Patient will get standard heparin dose of 5000 IU. And access site will be secured with TRB.
Intervention Type
Drug
Intervention Name(s)
LD+I+TRB
Other Intervention Name(s)
SD+I+TRB, LD+TRB
Intervention Description
Same as in the arm description
Primary Outcome Measure Information:
Title
Compression time
Description
Time from radial sheath removal to the time of TRB removal
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
radial artery occlusion
Description
Radial artery occlusion on colored doppler ultrasound
Time Frame
24 hours
Title
Hematoma at the access site
Description
Hematoma will be graded according to BRAC and BRAC III or IV will be considered as significant hematoma.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sana Sheikh, M.Sc
Phone
+92-21-36811841
Ext
1372
Email
sana.sheikh@tabbaheart.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sana Sheikh, M.Sc
Organizational Affiliation
Tabba Heart Institute
Official's Role
Study Director
Facility Information:
Facility Name
Sana
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75290
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sana Dr Sheikh, M. Sc

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will not be shared.

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Low Dose Heparin Factorial Trial

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