NCT00259194

Brief Summary

Coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding complications are often seen. To avoid/reduce bleeding complications digital compression is applied in the area of puncture during approximately 20 minutes and the patient is in the investigators' department observed in bed for 2 hours. The investigators apply pressure over the puncture site using a sand bag in the first hour. The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours (standard observation). In the present study the patients are randomized between standard observation and an alternative observation, where the patients are allowed to lift their head, arms and legs during the 2 hours, otherwise as standard observation. The study has three aims:

  • Frequency of hematoma (\> 5 cm)
  • Frequency of pseudoaneurysms
  • Frequency of bleeding demanding surgery
  • Frequency of bleeding demanding transfusion
  • Establish a model to predict in wich patient to expect a bleeding complication.
  • Assess if the alternative observation is associated with more bleeding complications compared to standard observation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

November 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

Enrollment Period

2 years

First QC Date

November 28, 2005

Last Update Submit

June 8, 2009

Conditions

Coronary ArteriosclerosisMyocardial Ischemia

Keywords

Coronary angiographyComplicationsObservation

Outcome Measures

Primary Outcomes (3)

  • Incidence of bleeding complications

    4 days

  • Model to predict bleeding complications

    4 days

  • Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications

    4 days

Study Arms (2)

Alternative Observation

ACTIVE COMPARATOR

Moving in bed during observation after coronary angiography

Behavioral: Moving

Standard Observation

EXPERIMENTAL

No moving in bed during observation after coronary angiography

Behavioral: No Moving

Interventions

MovingBEHAVIORAL

The patients are allowed to lift their head, arms and legs during the 2 hours.

Alternative Observation
No MovingBEHAVIORAL

The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours.

Standard Observation

Eligibility Criteria

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

You may qualify if:

  • Coronary angiography by the femoral access, where the arterial lumen is reached.
  • Only attempted puncture at one side.
  • Age \>= 18 years.

You may not qualify if:

  • Conditions that makes observation in the department impossible.
  • Dementia or other reasons to expect lack of compliance.
  • Previous participation in the project.
  • Implanted vascular prothesis at puncture site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Coronary Angiography Laboratory

Herning, 7400, Denmark

Location

Dept. of Med., Sect. of Cardology, Herning Hospital

Herning, 7400, Denmark

Location

Related Publications (2)

  • May O, Schlosser H, Skytte L. A high blood pressure predicts bleeding complications and a longer hospital stay after elective coronary angiography using the femoral approach. J Interv Cardiol. 2009 Apr;22(2):175-8. doi: 10.1111/j.1540-8183.2009.00427.x. Epub 2009 Feb 24.

    PMID: 19245381RESULT

  • May O, Schlosser H, Skytte L. A randomized trial assessing the influence of lying still or being allowed to move in the observation period following coronary angiography using the femoral approach. J Interv Cardiol. 2008 Aug;21(4):347-9. doi: 10.1111/j.1540-8183.2008.00359.x. Epub 2008 May 29.

    PMID: 18513345RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ole May, Dr.,Ph.D.

    Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2005

First Posted

November 29, 2005

Study Start

December 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

DK(2)