SAMOVAR: Immediate Mobilization After Cardiac Catheterisation

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Unknown status

CT.gov ID

NCT02069275

Collaborator

(none)

2,000

Enrollment

Location

Arms

Duration (Months)

45.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication Comfort	Other: Immediate mobilization Other: Two hours bedrest	N/A

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

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate mobilization Immediate mobilization after coronary angiography or percutaneous coronary intervention	Other: Immediate mobilization 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
Active Comparator: Two hours bedrest Bedrest two hours after coronary angiography or percutaneous coronary intervention	Other: Two 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

Arm

Intervention/Treatment

Experimental: Immediate mobilization

Immediate mobilization after coronary angiography or percutaneous coronary intervention

Other: Immediate mobilization

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

Active Comparator: Two hours bedrest

Bedrest two hours after coronary angiography or percutaneous coronary intervention

Other: Two 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.