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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate mobilization | Experimental | Immediate mobilization after coronary angiography or percutaneous coronary intervention |
|
| Two hours bedrest | Active Comparator | Bedrest two hours after coronary angiography or percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate mobilization | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma> 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 | participants will be followed for the duration of hospital stay, an expected average of 24 hours |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marianne W Noergaard, MVO | Contact | +45 35458869 | marianne.wetendorff.noergaard@regionh.dk | |
| Jane Faerch, MSc | Contact | +45 35452767 | jane.faerch.@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Marianne W Moergaard, MVO | Cardiac Cath.lab. Copenhagen University Hospital, Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet | Recruiting | Copenhagen | DK-2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34321432 | Derived | Norgaard MW, Faerch J, Joshi FR, Hofsten DE, Engstrom T, Kelbaek H. Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR): A Randomized Clinical Trial. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):E114-E121. doi: 10.1097/JCN.0000000000000845. Epub 2021 Jul 26. |
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| ID | Term |
|---|---|
| D001510 | Bed Rest |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Two hours bedrest | Other | 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 |
|
| 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 |