Immediate Mobilization After Cardiac Catheterisation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vascular Access Complication, Comfort

Intervention / Treatment
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* Other: Immediate mobilization
* Other: Two hours bedrest


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate mobilization<br>Immediate mobilization after coronary angiography or percutaneous coronary intervention | Other: Immediate mobilization<br>* 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<br>|
| Active Comparator: Two hours bedrest<br>Bedrest two hours after coronary angiography or percutaneous coronary intervention | Other: Two hours bedrest<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients comfort, Immediate mobilization, Bedrest, Coronary angiography, Coronary percutaneous intervention, Vascular access complications