Shortening Compression Time After Radial Access for Cardiac Catheterisation

NCT ID: NCT02398305

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

Brief Summary

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To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary intervention (PCI) the cardiologist can choose between the femoral artery and the radial artery. In the University Medical Center Groningen the femoral artery is commonly used. After intervention the puncture site is closed with an arteriotomy closure device (ACD). Patients after radial access receive a pressure bandage at the puncture site, usually the Terumo (TR) wrist bandage.

The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1 hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding complications after the procedure. In patients with radial access, the TR bandage will be removed according to current protocol after 4 hours and additionally 1 hour observation is required. Several cardiologists have the intention to use the radial artery more frequent for cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73% decrease in major bleeding complications compared to femoral access. Also there are no significant differences in MACE. Even so there are no differences in success percentage for cardiac catheterization or PCI and admission time is shorter for radial access (Am Heart J. 2009 Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the short-stay unit is in case of femoral access with an ACD approximately 2 hours. For patients after radial access post procedural admission time is approximately 5 hours. To guarantee patient throughput, uniformity of care and more efficient use of capacity of the short-stay unit, patients after radial access should not have a longer hospital admission time than patients after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown that it is safe to deflate the TR wrist band faster than four hours.

Objective of the study:

To describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.

Detailed Description

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Conditions

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Cardiac Catheterisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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TR Band accelerated

Diminishing air pressure in the TR Band using accelerated protocol

Group Type ACTIVE_COMPARATOR

TR Band Quick

Intervention Type DEVICE

Diminishing the air pressure in the TR Band following a faster protocol

TR band standard

Diminishing air pressure in the TR band according to standard care

Group Type OTHER

TR Band standard

Intervention Type DEVICE

Diminishing the air pressure in the TR Band following standard protocol

Interventions

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TR Band standard

Diminishing the air pressure in the TR Band following standard protocol

Intervention Type DEVICE

TR Band Quick

Diminishing the air pressure in the TR Band following a faster protocol

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnostic coronary angiogram
* Radial access
* 6 French sheath

Exclusion Criteria

* Use of oral anticoagulants
* Percutaneous coronary intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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J.H.H. (Han) Deuling

MANP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pim van der Harst, MD PhD

Role: STUDY_DIRECTOR

University Medical Center Groningen

Locations

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University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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METc2011-233

Identifier Type: -

Identifier Source: org_study_id

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