- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03558243
Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Intervention (PROTHECT)
Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Vascular Access for Diagnostic or Therapeutic Coronary Angiography
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jesus E Reyes, MD
- Phone Number: 1235 +525555732911
- Email: jesus1912@hotmail.com
Study Locations
-
-
Tlalpan
-
Mexico City, Tlalpan, Mexico, 14080
- Recruiting
- National Heart Institute
-
Contact:
- Jesus E Reyes, MD
- Phone Number: 1235 +525555732911
- Email: jesus1912@hotmail.com
-
Contact:
- Guering Eid-Lidt, MD
- Phone Number: 1235 +525555732911
- Email: guering@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients over 18 years of age, both genders, in whom successful transradial access is obtained for elective and urgent diagnostic or therapeutic coronary procedures.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Patent Hemostasis Arm
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.
|
Patent hemostasis with TR BAND
|
Experimental: ULTRA Arm
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.
|
Patent hemostasis protocol plus ipsilateral ulnar compression
|
Experimental: Hemostatic Disc Arm
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.
|
StatSeal disc plus TR Band
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Measured with Barbeau test. |
24 Hours and 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular Complications
Time Frame: 30 days
|
1. 2 items
|
30 days
|
Hemorrhagic Complications
Time Frame: 24 hours
|
1. 2 items
|
24 hours
|
Radial artery occlusion according to heparin dose
Time Frame: 30 days
|
1. 3 items
|
30 days
|
Radial artery occlusion according to sheath size
Time Frame: 30 days
|
1. 3 items
|
30 days
|
Time to TR Band removal
Time Frame: 300 Minutes
|
1. 1 Item - Averaged time until TR band removal |
300 Minutes
|
Radial artery occlusion according to type of procedure
Time Frame: 30 days
|
1. 2 items
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Guering Eid-Lidt, MD, National Heart Institute, Mexico
- Study Chair: Marco A Peña, MD, National Heart Institute, Mexico
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT-18-075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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