Immediate Mobilization After Cardiac Catheterisation

Vascular Access Complication Clinical Trial

— SAMOVAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02069275
• Other study ID #: SAMOVAR 01
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2014
• Last updated: June 30, 2016
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Rigshospitalet, Denmark
• Contact: Marianne W Noergaard, MVO
• Phone: +45 35458869
• Email: marianne.wetendorff.noergaard[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Comfort
• Vascular Access Complication

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
• 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

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The presence of hematoma> 10 cm in diameter		participants will be followed for the duration of hospital stay, an expected average of 24 hours	Yes
Secondary	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	Yes
Secondary	Oozing or bleeding from the puncture site		participants will be followed for the duration of hospital stay, an expected average of 24 hours	Yes
Secondary	Comfort rating (NRS scale)		Two hours after the procedure	No