Occlusion of ArteryPROTHECTNCT03558243
Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Intervention
A study testing Patent Hemostasis arm, ULTRA arm and Hemostatic disc arm in people with Occlusion of Artery and Radial Artery Injury, run by National Heart Institute, Mexico at 1 site in Mexico.
Trial summary
This study evaluates three hemostatic methods for prevention of radial artery occlusion. One third of patients will receive patent hemostasis, another third will receive patent hemostasis plus ulnar compression and the last third will receive the StatSeal hemostatic disc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occlusion of Artery, Radial Artery Injury, Complication
- What is being tested?
- Patent Hemostasis arm, ULTRA arm and Hemostatic disc arm
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,425 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2018to 30 Oct 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age, both genders, in whom successful transradial access is obtained for elective and urgent diagnostic or therapeutic coronary procedures.
Who cannot join
- Patients over 18 years of age, both genders, in whom successful transradial access is not achieved and crossover is performed to femoral access.
- Patients over 18 years of age, both genders, who do not give their informed consent to participate in the study.
- Patients over 18 years, both genders, with cardiogenic shock.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Heart Institute
Mexico City, Tlalpan, 14080
Jesus E Reyes, MD, +525555732911 ext. 1235, jesus1912@hotmail.com
Guering Eid-Lidt, MD, +525555732911 ext. 1235, guering@yahoo.com
About this study
Official title: Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Vascular Access for Diagnostic or Therapeutic Coronary Angiography
This study evaluates three hemostatic methods for prevention of radial artery occlusion. One third of patients will receive patent hemostasis, another third will receive patent hemostasis plus ulnar compression and the last third will receive the StatSeal hemostatic disc.
Read the detailed description
The main complication of the transradial access is the occlusion of the radial artery, which although clinically silent in most cases, has been associated with critical hand ischemia, more importantly it limits the radial approach for future coronary interventions, and limits the use of this conduit for coronary revascularization surgery and arteriovenous fistulas.
Factors that prevent occlusion of the radial artery have been identified, including the use of several hemostatic techniques at the conclusion of cardiac catheterization.
The patent hemostasis defined as a technique that allows permeability of the radial artery and at the same time ensures the absence of bleeding was the first hemostatic method that showed a decrease in the incidence of radial artery occlusion, it is currently the quality standard for hemostasis in transradial access worldwide. Recently, the patent hemostasis plus ulnar compression was described, which proved in a randomized clinical trial to be superior to conventional patent haemostasis, decreasing the incidence of radial artery occlusion to 0.8% at 30 days. These hemostatic methods are a subject of current research worldwide. And more clinical trials are expected to confirm the superiority of patent hemostasis plus ulnar compression.
The hemostatic discs used at the beginning as an attempt to reduce the times for the hemostasis of the radial access and therefore the recovery times in units of high volume have attracted attention for their effectiveness and their low incidence of radial artery occlusion, there are few reports who place it as a potential strategy to reduce the incidence of radial artery occlusion. Its effectiveness should be validated in dedicated trials with an adequate sample size.
- Conditions
- Occlusion of Artery, Radial Artery Injury, Complication
- Being tested
- Patent Hemostasis arm, ULTRA arm, Hemostatic disc arm
- Keywords
- radial artery occlusion, prevention, patent hemostasis, transradial intervention, ulnar compression
- 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.
Patent Hemostasis armProcedure or surgery
Patent hemostasis with TR BAND
ULTRA armProcedure or surgery
Patent hemostasis protocol plus ipsilateral ulnar compression
Hemostatic disc armDevice
StatSeal disc plus TR Band
| Study group | Role | What they receive |
|---|---|---|
| Patent Hemostasis Arm | Active comparator | The TR Band (Terumo medical) will be placed on the sheath entry site, the air bladder of the TR Band will be filled with 18 mL of air to achieve initial hemostasis. The sheath will be removed, air will be withdrawn slowly until a pulsatile bleeding is observed through the sheath's orifice, once this phenomenon occurs, 2 ml of air will be added to the air bladder and the absence of bleeding will be corroborated, immediately afterwards a pulse oximeter will be placed on the index finger of the patient and transient manual compression of the ipsilateral ulnar artery will be performed, patency of the radial artery will be corroborated by means of oxygen saturation and adequate pulse curve (Barbeau reverse test), if it is not possible to achieve patent hemostasis, it will be retried deflating 1-2 ml of the TR Band every 15 minutes until a positive reverse Barbeau test with absence of bleeding is achieved. TR Band removal will be attempted 2 hours after the procedure. Receives: Procedure: Patent Hemostasis arm |
| ULTRA Arm | Experimental | The TR Band will be placed at the sheath entry site, the ipsilateral ulnar artery will be compressed at the Guyon's canal by placing a cylindrical composite made by wrapping 4 inch x 4 inch gauze around a 1-inch plastic needle cap, and compressing it using a circumferentially applied Hemoband. After occlusive compression of ulnar artery is confirmed by means of plethysmography, patent hemostasis protocol will be used for radial artery hemostasis as described at the patent hemostasis arm. The needle cap and hemoband that compresses the ulnar artery will be removed 1 hour after the procedure. TR Band removal will be attempted 2 hours after the procedure. Receives: Procedure: ULTRA arm |
| Hemostatic Disc Arm | Experimental | The StatSeal hemostatic disc will be placed above sheath entry site, the TR Band will be placed above the disc, according to the manufacturer's specifications the air bladder will be filled with 8 ml of air, the sheath will be then removed, corroborating the absence of bleeding, 20 minutes later 3 ml of air will be removed, 20 minutes after that 5 ml of air will be removed, finally the investigators will try to remove the deflated TR Band 60 minutes after the procedure. Receives: Device: Hemostatic disc arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion (RAO) according to hemostatic technique at 24 hrs and evaluate change at 30 days
2 Items.
- RAO at 24 hrs
- RAO at 30 days
Measured with Barbeau test.
Measured: 24 Hours and 30 days
Secondary outcomes (6)
Vascular Complications
- 2 items
- Radial arteriovenous fistula
- Radial pseudoaneurysm
Measured: 30 days
Hemorrhagic Complications
- 2 items
- Thrombolysis In Myocardial Infarction criteria, Non Coronary Artery Bypass Grafting related bleeding
- Major bleeding
- Minor bleeding
- Minimal bleeding
- Hematoma formation EASY hematoma scale
- Grade 1
- Grade II
- Grade III
- Grade IV
- Grade V
Measured: 24 hours
Radial artery occlusion according to heparin dose
- 3 items
- RAO with < 5000 Ui heparin dose
- RAO with 5000-8000 Ui heparin dose
- RAO with > 8000 heparin dose
Measured: 30 days
Radial artery occlusion according to sheath size
- 3 items
- RAO with 5 Fr Sheath's
- RAO with 6 Fr Sheath's
- RAO with 7 Fr Sheath´s
Measured: 30 days
Time to TR Band removal
- 1 Item
- Averaged time until TR band removal
Measured: 300 Minutes
Radial artery occlusion according to type of procedure
- 2 items
- RAO in diagnostic procedures
- RAO in therapeutic procedures
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 May 2018
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusion of ArteryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Institute, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jesus Reyes, National Heart Institute, Mexico
- Investigators
- Guering Eid-Lidt, MD, Study director, National Heart Institute, MexicoMarco A Peña, MD, Study chair, National Heart Institute, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558243
- Sponsor's protocol ID
- PT-18-075
- Acronym
- PROTHECT
- Status last verified
- Mar 2020
- First submitted
- 8 May 2018
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual patient data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Vascular Access for Diagnostic or Therapeutic Coronary Angiography
- ClinicalTrials.gov ID
- NCT03558243
- Acronym / sponsor ID
- PROTHECT / PT-18-075
- Conditions
- Occlusion of Artery, Radial Artery Injury, Complication
- Keywords
- radial artery occlusion, prevention, patent hemostasis, transradial intervention, ulnar compression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,425 participants (estimated)
- Lead sponsor
- National Heart Institute, MexicoOther government
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 15 Jun 2018 (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.
This study evaluates three hemostatic methods for prevention of radial artery occlusion. One third of patients will receive patent hemostasis, another third will receive patent hemostasis plus ulnar compression and the last third will receive the StatSeal hemostatic disc.
Detailed description
The main complication of the transradial access is the occlusion of the radial artery, which although clinically silent in most cases, has been associated with critical hand ischemia, more importantly it limits the radial approach for future coronary interventions, and limits the use of this conduit for coronary revascularization surgery and arteriovenous fistulas.
Factors that prevent occlusion of the radial artery have been identified, including the use of several hemostatic techniques at the conclusion of cardiac catheterization.
The patent hemostasis defined as a technique that allows permeability of the radial artery and at the same time ensures the absence of bleeding was the first hemostatic method that showed a decrease in the incidence of radial artery occlusion, it is currently the quality standard for hemostasis in transradial access worldwide. Recently, the patent hemostasis plus ulnar compression was described, which proved in a randomized clinical trial to be superior to conventional patent haemostasis, decreasing the incidence of radial artery occlusion to 0.8% at 30 days. These hemostatic methods are a subject of current research worldwide. And more clinical trials are expected to confirm the superiority of patent hemostasis plus ulnar compression.
The hemostatic discs used at the beginning as an attempt to reduce the times for the hemostasis of the radial access and therefore the recovery times in units of high volume have attracted attention for their effectiveness and their low incidence of radial artery occlusion, there are few reports who place it as a potential strategy to reduce the incidence of radial artery occlusion. Its effectiveness should be validated in dedicated trials with an adequate sample size.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Patent Hemostasis Arm | Active comparator | Procedure: Patent Hemostasis armThe TR Band (Terumo medical) will be placed on the sheath entry site, the air bladder of the TR Band will be filled with 18 mL of air to achieve initial hemostasis. The sheath will be removed, air will be withdrawn slowly until a pulsatile bleeding is observed through the sheath's orifice, once this phenomenon occurs, 2 ml of air will be added to the air bladder and the absence of bleeding will be corroborated, immediately afterwards a pulse oximeter will be placed on the index finger of the patient and transient manual compression of the ipsilateral ulnar artery will be performed, patency of the radial artery will be corroborated by means of oxygen saturation and adequate pulse curve (Barbeau reverse test), if it is not possible to achieve patent hemostasis, it will be retried deflating 1-2 ml of the TR Band every 15 minutes until a positive reverse Barbeau test with absence of bleeding is achieved. TR Band removal will be attempted 2 hours after the procedure. |
| ULTRA Arm | Experimental | Procedure: ULTRA armThe TR Band will be placed at the sheath entry site, the ipsilateral ulnar artery will be compressed at the Guyon's canal by placing a cylindrical composite made by wrapping 4 inch x 4 inch gauze around a 1-inch plastic needle cap, and compressing it using a circumferentially applied Hemoband. After occlusive compression of ulnar artery is confirmed by means of plethysmography, patent hemostasis protocol will be used for radial artery hemostasis as described at the patent hemostasis arm. The needle cap and hemoband that compresses the ulnar artery will be removed 1 hour after the procedure. TR Band removal will be attempted 2 hours after the procedure. |
| Hemostatic Disc Arm | Experimental | Device: Hemostatic disc armThe StatSeal hemostatic disc will be placed above sheath entry site, the TR Band will be placed above the disc, according to the manufacturer's specifications the air bladder will be filled with 8 ml of air, the sheath will be then removed, corroborating the absence of bleeding, 20 minutes later 3 ml of air will be removed, 20 minutes after that 5 ml of air will be removed, finally the investigators will try to remove the deflated TR Band 60 minutes after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age, both genders, in whom successful transradial access is obtained for elective and urgent diagnostic or therapeutic coronary procedures.
Key exclusion criteria (3 listed)
- Patients over 18 years of age, both genders, in whom successful transradial access is not achieved and crossover is performed to femoral access.
- Patients over 18 years of age, both genders, who do not give their informed consent to participate in the study.
- Patients over 18 years, both genders, with cardiogenic shock.
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 |
|---|---|---|
| Patent Hemostasis armPatent hemostasis with TR BAND | Procedure or surgery | Patent Hemostasis Arm |
| ULTRA armPatent hemostasis protocol plus ipsilateral ulnar compression | Procedure or surgery | ULTRA Arm |
| Hemostatic disc armStatSeal disc plus TR Band | Device | Hemostatic Disc Arm |
Primary outcome
Radial artery occlusion (RAO) according to hemostatic technique at 24 hrs and evaluate change at 30 days
Time frame: 24 Hours and 30 days
2 Items. * RAO at 24 hrs * RAO at 30 days Measured with Barbeau test.
6 secondary outcomes
Vascular Complications
Time frame: 30 days
Hemorrhagic Complications
Time frame: 24 hours
Radial artery occlusion according to heparin dose
Time frame: 30 days
Radial artery occlusion according to sheath size
Time frame: 30 days
Time to TR Band removal
Time frame: 300 Minutes
Radial artery occlusion according to type of procedure
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No. The individual patient data will not be shared with other researchers
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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.
Guering Eid-Lidt, MD study director
National Heart Institute, Mexico
Marco A Peña, MD study chair
National Heart Institute, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patent Hemostasis arm, ULTRA arm and Hemostatic disc arm in people with Occlusion of Artery and Radial Artery Injury, run by National Heart Institute, Mexico at 1 site in Mexico.
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 3 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 19 Mar 2020. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesus E Reyes, MD (+525555732911 ext. 1235, jesus1912@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery occlusion (RAO) according to hemostatic technique at 24 hrs and evaluate change at 30 days (time frame: 24 Hours and 30 days). 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 19 Mar 2020.