NCT02069275

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

3.6 years

First QC Date

February 13, 2014

Last Update Submit

June 30, 2016

Conditions

Vascular Access ComplicationComfort

Keywords

Immediate mobilizationBedrestCoronary angiographyCoronary percutaneous interventionVascular access complicationsPatients comfort

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

Study Arms (2)

Immediate mobilization

EXPERIMENTAL

Immediate mobilization after coronary angiography or percutaneous coronary intervention

Other: Immediate mobilization

Two hours bedrest

ACTIVE COMPARATOR

Bedrest two hours after coronary angiography or percutaneous coronary intervention

Other: Two hours bedrest

Interventions

Immediate mobilizationOTHER

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

Immediate mobilization
Two hours bedrestOTHER

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

Two hours bedrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CAG or PCI performed via the femoral artery
  • No hematoma in the groin (\> 5 cm in diameter)
  • Heparin reversed with protamine after PCI

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, DK-2100, Denmark

RECRUITING

Related Publications (1)

  • Norgaard MW, Faerch J, Joshi FR, Hofsten DE, Engstrom T, Kelbaek H. Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR): A Randomized Clinical Trial. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):E114-E121. doi: 10.1097/JCN.0000000000000845. Epub 2021 Jul 26.

    PMID: 34321432DERIVED

MeSH Terms

Interventions

Bed Rest

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Marianne W Moergaard, MVO

    Cardiac Cath.lab. Copenhagen University Hospital, Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne W Noergaard, MVO

CONTACT

+45 35458869marianne.wetendorff.noergaard@regionh.dk

Jane Faerch, MSc

CONTACT

+45 35452767jane.faerch.@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 24, 2014

Study Start

April 1, 2013

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

DK(1)