Differences in Radial Artery Occlusion From Two Different Compressive Methods Used in Patients in Order to Achieve Homeostasis After Transradial Catheterization and Their Repercussion in Artery Functionality and Hand Mobility

February 26, 2016 updated by: Hospital Universitari Vall d'Hebron Research Institute

Influence of the Compression Method After Transradial Catheterization in Radial Artery

The aim of the study is to determine differences on radial artery occlusion from two compressive methods used after transradial catheterization and its functional impact on hand mobility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Changes in Allen's test and pulse oximetry will be evaluated at baseline, 1 week and 3 month of catheterization in both groups of patients in order to check the functionality of the communications between the ulnar and radial arteries. The repercussion of each compressive method on radial occlusion and artery revascularization will be assessed by eco-Doppler at any time. Changes in diameter of arterial lumen of radial and ulnar arteries as a consequence of radial occlusion will be done simultaneously of blood flow Doppler measurements. The possible impact of radial occlusion on hand mobility will be done using a dynamometer designed to evaluate strength (Endurance test) and muscular claudication (Rapid exchange test).

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in whom at least the diagnostic catheterization has been done successfully by the radial artery route.
  • Patients with a negative Allen's Clinical test showing hyperemia before 9 seconds after pressure release over the ulnar artery pulse.
  • Patients showing a Barbeau pattern A,B or C with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
  • Patients that will be able to do the follow up visits at 1 week and 3 month.
  • Signature of informed consent

Exclusion Criteria:

  • Patients in that neither the diagnostic or therapeutic procedure has successfully done via the radial artery route.
  • Patients with a positive Allen's test (no hyperemia) after pressure and release over the ulnar artery pulse.
  • Patients showing a Barbeau pattern D with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
  • Inability to visit at 1 week and 3 month.
  • Impossibility to obtain informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Terumo
Patients in this arm will receive Terumo after catheterization
Other: Terumo
Other: Tensoplast
Patients in this arm will receive Tensoplast after catheterization
Other: Tensoplast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of radial artery occlusion at baseline (before catheterization)
Time Frame: 1 day
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
1 day
Determination of radial artery occlusion after catheterization
Time Frame: 1 week
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
1 week
Determination of radial artery occlusion after catheterization
Time Frame: 3 month
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomic differences in radial and ulnar diameters
Time Frame: 3 month
Anatomic differences in arterial lumen of radial and ulnar arteries (diameter)
3 month
Differences in radial and ulnar blood flow between compression methods
Time Frame: 3 month
Differences in radial and ulnar blood flow as a consequence of radial occlusion
3 month
Differences in functional status at follow between compression groups
Time Frame: 1 day
Differences in hand mobility at baseline, 1 week and 3 month of catheterization as a consequence of radial occlusion in relation with the compressive method used to achieve homeostasis.
1 day
Differences in functional status at follow between compression groups
Time Frame: 1 week
Differences in hand mobility at baseline, 1 week and 3 month of catheterization as a consequence of radial occlusion in relation with the compressive method used to achieve homeostasis.
1 week
Differences in functional status at follow between compression groups
Time Frame: 3 month
Differences in hand mobility at baseline, 1 week and 3 month of catheterization as a consequence of radial occlusion in relation with the compressive method used to achieve homeostasis.
3 month
Differences in functional status between occluded radial cohort and patent radial cohort
Time Frame: 1 day
Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion.
1 day
Differences in functional status between occluded radial cohort and patent radial cohort
Time Frame: 1 week
Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion.
1 week
Differences in functional status between occluded radial cohort and patent radial cohort
Time Frame: 3 month
Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Bruno García del Blanco, MD, PhD, Hospital Universitari Vall d'Hebron (Barcelona)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR(AG)70/2006

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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