HemostasisGOLOWNCT04593667
Randomized Study of Accelerated Radial Arterial Hemostasis
A study testing hm-P bandage in people with Hemostasis, run by Medcura Inc. at 1 site in United States.
Trial summary
Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemostasis
- What is being tested?
- hm-P bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 14 Jul 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Lenox Hill Hospital - Northwell Health
New York, New York, 10075
About this study
Official title: Utilizing a Novel Agent in a Randomized Study of Accelerated Radial Arterial Hemostasis Under Reduced Compression Following Percutaneous Transradial Coronary Angiography/Intervention
Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage
Read the detailed description
The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, \& N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.
- Conditions
- Hemostasis
- Being tested
- hm-P bandage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hm-P bandageDevice
hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.
| Study group | Role | What they receive |
|---|---|---|
| Full Inflation | Other | 100% TR Band inflation relative to recommended inflation with 15-18 cc air injected in TR band bladder Receives: Device: hm-P bandage |
| Mid Inflation | Other | 75% TR Band inflation relative to recommended inflation with 11-14 cc air injected in TR band bladder Receives: Device: hm-P bandage |
| Low Inflation | Other | 50% TR Band inflation relative to recommended inflation with 8-9 cc air injected in TR band bladder Receives: Device: hm-P bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemostasis
Significant change in time to hemostasis
Measured: 60 minutes
Compressive Force
Change in the compressive force onto the access site
Measured: 60 minutes
Secondary outcomes (1)
Radial Artery
Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test
Measured: immediately after hemostasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start9 Nov 2020
- Primary completion9 Dec 2020
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 patients, randomized into one of three arms
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medcura Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Responsible party
- Sponsor
- Investigators
- Varinder Singh, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593667
- Sponsor's protocol ID
- WIRB Protocol 20202766
- Other IDs
- 1291856
- Acronym
- GOLOW
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing a Novel Agent in a Randomized Study of Accelerated Radial Arterial Hemostasis Under Reduced Compression Following Percutaneous Transradial Coronary Angiography/Intervention
- ClinicalTrials.gov ID
- NCT04593667
- Acronym / sponsor ID
- GOLOW / WIRB Protocol 20202766
- Conditions
- Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medcura Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 20 Oct 2020 (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.
Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage
Detailed description
The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, \& N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 60 patients, randomized into one of three arms
| Arm | Type | Receives |
|---|---|---|
| Full Inflation | Other | Device: hm-P bandage100% TR Band inflation relative to recommended inflation with 15-18 cc air injected in TR band bladder |
| Mid Inflation | Other | Device: hm-P bandage75% TR Band inflation relative to recommended inflation with 11-14 cc air injected in TR band bladder |
| Low Inflation | Other | Device: hm-P bandage50% TR Band inflation relative to recommended inflation with 8-9 cc air injected in TR band bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| hm-P bandagehm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation. | Device | Full Inflation, Low Inflation, Mid Inflation |
Primary outcome
Time to hemostasis
Time frame: 60 minutes
Significant change in time to hemostasis
Compressive Force
Time frame: 60 minutes
Change in the compressive force onto the access site
1 secondary outcome
Radial Artery
Time frame: immediately after hemostasis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Varinder Singh, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hm-P bandage in people with Hemostasis, run by Medcura Inc. at 1 site in United States.
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: finished, as of the sponsor's last update on 8 Sep 2021. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hemostasis (time frame: 60 minutes). The study lists 2 primary outcomes in all. 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 8 Sep 2021.