Observation and Prediction of Complications After Coronary Angiography (OPKAT)

June 8, 2009 updated by: Herning Hospital

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:

  1. To establish the incidence of bleeding complications:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

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 Locations

  • Denmark
      • Herning, Denmark, 7400
        • Coronary Angiography Laboratory
      • Herning, Denmark, 7400
        • Dept. of Med., Sect. of Cardology, Herning Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alternative Observation
Moving in bed during observation after coronary angiography
Behavioral: Moving
The patients are allowed to lift their head, arms and legs during the 2 hours.
Experimental: Standard Observation
No moving in bed during observation after coronary angiography
Behavioral: No Moving
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of bleeding complications
Time Frame: 4 days
4 days
Model to predict bleeding complications
Time Frame: 4 days
4 days
Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications
Time Frame: 4 days
4 days

Collaborators and Investigators

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

Sponsor

Herning Hospital

Collaborators

The Medical Research Fund of the County of Ringkøbing

Investigators

  • Study Chair: Ole May, Dr.,Ph.D., Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning

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

December 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 28, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

June 11, 2009

Last Update Submitted That Met QC Criteria

June 8, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPKAT

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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