Immediate Mobilization After Cardiac Catheterisation

Not Applicable

• Conditions: Vascular Access Complication; Comfort
• Interventions: Other: Immediate mobilization; Other: Two hours bedrest

• Registration Number: NCT02069275
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-24
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-07-01
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate mobilization	Immediate mobilization	Immediate mobilization after coronary angiography or percutaneous coronary intervention
Two hours bedrest	Two hours bedrest	Bedrest two hours after coronary angiography or percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
The presence of hematoma> 10 cm in diameter	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

Trial Locations

Locations (1)

Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark