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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02398305
Enrollment
173
Registered
2015-03-25
Start date
2012-10-31
Completion date
2013-08-31
Last updated
2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Catheterisation

Keywords

Cardiac catheterisation, Radial access, Compression, Terumo TR Band, radial artery, diagnostic

Brief 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.

Interventions

DEVICETR Band standard

Diminishing the air pressure in the TR Band following standard protocol

DEVICETR Band Quick

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

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Diagnostic coronary angiogram * Radial access * 6 French sheath

Exclusion criteria

* Use of oral anticoagulants * Percutaneous coronary intervention

Design outcomes

Primary

MeasureTime frameDescription
Bleeding1 yearBleeding at puncture site after deflating pressure in TR band

Secondary

MeasureTime frameDescription
Swelling1 yearSwelling at puncture site that is not caused by bleeding
Patient comfort1 yearPatient comfort, measured on VAS
Time to discharge, after return on nursing unit1 year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026