Comfort, Vascular Access Complication
Conditions
Keywords
Immediate mobilization, Bedrest, Coronary angiography, Coronary percutaneous intervention, Vascular access complications, Patients comfort
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.
Interventions
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
OTHERTwo hours bedrest
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
Sponsors
Rigshospitalet, Denmark
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma> 5 cm | 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
| Measure | Time frame |
|---|---|
| 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 |
| Comfort rating (NRS scale) | Two hours after the procedure |
Countries
Denmark
Contacts
Primary ContactMarianne W Noergaard, MVO
Backup ContactJane Faerch, MSc
Outcome results
None listed