Patients Immediate Mobilization After Coronary Angiography and Percutaneous Coronary Intervention. Is it SAfe to MObilize Patients Very eARly After Cardiac Catheterisation?
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Hematoma> 5 cm
Study Overview
Brief 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.
Detailed 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CAG or PCI performed via the femoral artery
- •No hematoma in the groin (> 5 cm in diameter)
- •Heparin reversed with protamine after PCI
Exclusion Criteria
- •Oozing, bleeding or hematoma
- •Treatment with Integrilin, ReoPro, or Marevan
- •Heparin can not be reversed
- •The patient does not want to participate
- •Systolic blood pressure > 180 mm Hg after the procedure
- •BMI> 35 (can be modified if the groin can be assessed in an upright position)
- •Demented, unconscious patients who do not understand the information for participants.
Arms & Interventions
Immediate mobilization
Immediate mobilization after coronary angiography or percutaneous coronary intervention
Intervention: Immediate mobilization (Other)
Two hours bedrest
Bedrest two hours after coronary angiography or percutaneous coronary intervention
Intervention: Two hours bedrest (Other)
Outcomes
Primary Outcomes
Hematoma> 5 cm
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
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
Secondary Outcomes
- Comfort rating (NRS scale)(Two hours after the procedure)
- The presence of hematoma> 10 cm in diameter(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(participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Oozing or bleeding from the puncture site(participants will be followed for the duration of hospital stay, an expected average of 24 hours)
Investigators
Marianne Wetendorff Noergaard
Clinical Nurse Specialist
Rigshospitalet, Denmark