Immediate Mobilization After Cardiac Catheterisation (SAMOVAR)

Rigshospitalet

Status: Unknown

Conditions: Vascular Access Complication; Comfort

Treatments: Other: Two hours bedrest; Other: Immediate mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT02069275

SAMOVAR 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Immediate mobilization

Experimental group

Description:

Immediate mobilization after coronary angiography or percutaneous coronary intervention

Treatment:

Other: Immediate mobilization

Two hours bedrest

Active Comparator group

Description:

Bedrest two hours after coronary angiography or percutaneous coronary intervention

Treatment:

Other: Two hours bedrest