Radial Artery OcclusionPhase 3NCT05591872
Low Dose Heparin Factorial Trial
A Phase 3 study testing LD+I+TRB in people with Radial Artery Occlusion, run by Tabba Heart Institute at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion
- What is being tested?
- LD+I+TRB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 sitePakistan
- Study dates
- 9 May 2022to 31 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodynamically stable adult patients of both genders, who will undergo transradial coronary angiogram (CAG) using 6 F sheath will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Sana
Karachi, Sindh, 75290
Sana Dr Sheikh, M. Sc
About this study
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).
Read the 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.
- Conditions
- Radial Artery Occlusion
- Being tested
- LD+I+TRB
- Keywords
- radial artery occlusion, left heart catheterization, heparin, hemostatic patch
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LD+I+TRBDrug
Also called SD+I+TRB, LD+TRB
Same as in the arm description
| Study group | Role | What they receive |
|---|---|---|
| LD+I+TRB | Active comparator | 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 Receives: Drug: LD+I+TRB |
| LD+TRB | Active comparator | 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 Receives: Drug: LD+I+TRB |
| SD+I+TRB | Active comparator | Patient will get standard heparin dose of 5000 IU.
And access site will be secured with InnoSEAL patch plus TRB Receives: Drug: LD+I+TRB |
| SD+TRB | No intervention | This is the control arm. Patient will get standard heparin dose of 5000 IU. And access site will be secured with TRB. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compression time
Time from radial sheath removal to the time of TRB removal
Measured: 45 minutes
Secondary outcomes (2)
radial artery occlusion
Radial artery occlusion on colored doppler ultrasound
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start9 May 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabba Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- InnoTherapy Inc
- Responsible party
- Sponsor
- Investigators
- Sana Sheikh, M.Sc, Study director, Tabba Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591872
- Sponsor's protocol ID
- THI-INNOSEAL3-2022
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05591872
- Acronym / sponsor ID
- THI-INNOSEAL3-2022
- Conditions
- Radial Artery Occlusion
- Keywords
- radial artery occlusion, left heart catheterization, heparin, hemostatic patch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Tabba Heart InstituteUniversity, hospital or other
- Collaborators
- InnoTherapy Inc
- Study start
- 9 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| LD+I+TRB | Active comparator | Drug: LD+I+TRBPatient 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 |
| LD+TRB | Active comparator | Drug: LD+I+TRBPatient 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 |
| SD+I+TRB | Active comparator | Drug: LD+I+TRBPatient will get standard heparin dose of 5000 IU. And access site will be secured with InnoSEAL patch plus TRB |
| SD+TRB | No intervention | –This is the control arm. Patient will get standard heparin dose of 5000 IU. And access site will be secured with TRB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemodynamically stable adult patients of both genders, who will undergo transradial coronary angiogram (CAG) using 6 F sheath will be included.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LD+I+TRBAlso: SD+I+TRB, LD+TRBSame as in the arm description | Drug | LD+I+TRB, LD+TRB, SD+I+TRB |
Primary outcome
Compression time
Time frame: 45 minutes
Time from radial sheath removal to the time of TRB removal
2 secondary outcomes
radial artery occlusion
Time frame: 24 hours
Hematoma at the access site
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: No. Individual data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sana Sheikh, M.Sc study director
Tabba Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LD+I+TRB in people with Radial Artery Occlusion, run by Tabba Heart Institute at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sana Sheikh, M.Sc (+92-21-36811841 ext. 1372, sana.sheikh@tabbaheart.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compression time (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.