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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2,000
Patients are mobilized immediate after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device. Heparin reverted with Protaminsulphate
Patients is following the usual regimen, two hours bedrest after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device before mobilization. Heparin is reverted with Protaminsulphate
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
RECRUITINGHematoma> 5 cm
occurred after the end of the procedure, including retroperitoneal hematoma, bleeding requiring transfusion or pseudoaneurysm that require vascular surgical intervention. Assessed after 30 minutes, after two hours and before discharge
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
The presence of hematoma> 10 cm in diameter
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
The presence of hematoma 2-5 cm in diameter
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Oozing or bleeding from the puncture site
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Comfort rating (NRS scale)
Time frame: Two hours after the procedure
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