Immediate Mobilization After Cardiac Catheterisation (SAMOVAR)

June 30, 2016 updated by: Marianne Wetendorff Noergaard, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematoma> 5 cm
Time Frame: 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
participants will be followed for the duration of hospital stay, an expected average of 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The presence of hematoma> 10 cm in diameter
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
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
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
participants will be followed for the duration of hospital stay, an expected average of 24 hours
Oozing or bleeding from the puncture site
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
participants will be followed for the duration of hospital stay, an expected average of 24 hours
Comfort rating (NRS scale)
Time Frame: Two hours after the procedure
Two hours after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Marianne W Moergaard, MVO, Cardiac Cath.lab. Copenhagen University Hospital, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAMOVAR 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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