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Immediate Mobilization After Cardiac Catheterisation — SAMOVAR  

Vascular Access Complication Clinical Trial

Official title:
Patients Immediate Mobilization After Coronary Angiography and Percutaneous Coronary Intervention. Is it SAfe to MObilize Patients Very eARly After Cardiac Catheterisation?

Clinical Trial Summary

The purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). At the same time the investigators will investigate whether it reduces the discomfort being mobilized immediately after the procedure.

Clinical Trial Description

The frequency of hematoma, bleeding or pseudoaneurysm at the access site in the groin is 7-15% with regimens that involve 0-2 hours of bed rest, somewhat more frequent after Percutaneous coronary intervention (PCI) than coronary angiography (CAG). There seems to be no reduction in the complications of the CAG or PCI by maintaining the bed rest for more than 2 hours after the procedure. Angio-Seal seems most effective of current closure devices. There is less discomfort associated with early compared with late mobilization. Protamine reverse heparin's effect without the side effects of that regime.

There lacks a larger randomized study of the safety of mobilizing patients immediately after CAG and after PCI. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02069275
Study type Interventional
Source Rigshospitalet, Denmark
Contact Marianne W Noergaard, MVO
Phone +45 35458869
Email marianne.wetendorff.noergaard@regionh.dk
Status Recruiting
Phase N/A
Start date April 2013
Completion date December 2016
View Details
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