NCT02697526

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

February 23, 2016

Last Update Submit

February 26, 2016

Conditions

Keywords

radial arteryocclusionfunctionalcomplicationsconsequences

Outcome Measures

Primary Outcomes (3)

  • Determination of radial artery occlusion at baseline (before catheterization)

    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

    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

    Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods

    3 month

Secondary Outcomes (8)

  • Anatomic differences in radial and ulnar diameters

    3 month

  • Differences in radial and ulnar blood flow between compression methods

    3 month

  • Differences in functional status at follow between compression groups

    1 day

  • Differences in functional status at follow between compression groups

    1 week

  • Differences in functional status at follow between compression groups

    3 month

  • +3 more secondary outcomes

Study Arms (2)

Terumo

OTHER

Patients in this arm will receive Terumo after catheterization

Other: Terumo

Tensoplast

OTHER

Patients in this arm will receive Tensoplast after catheterization

Other: Tensoplast

Interventions

TerumoOTHER
Terumo
Tensoplast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (65)

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MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Bruno García del Blanco, MD, PhD

    Hospital Universitari Vall d'Hebron (Barcelona)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 3, 2016

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 3, 2016

Record last verified: 2016-02

Locations