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Trials / Completed

CompletedNCT02398305

Shortening Compression Time After Radial Access for Cardiac Catheterisation

Shortening Compression Time of the Access Site After Cardiac Catheterisation Through the Radial Artery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
173 (actual)
Sponsor
University Medical Center Groningen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICETR Band standardDiminishing the air pressure in the TR Band following standard protocol
DEVICETR Band QuickDiminishing the air pressure in the TR Band following a faster protocol

Timeline

Start date
2012-10-01
Primary completion
2013-07-01
Completion
2013-08-01
First posted
2015-03-25
Last updated
2015-03-25

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02398305. Inclusion in this directory is not an endorsement.