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OpenTrials
Completed

NCT Number: NCT00259194

Observation and Prediction of Complications After Coronary Angiography

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coronary Angiography Laboratory, Herning, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Moving

Behavioral

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

No Moving

Behavioral

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.

Primary outcomes

  1. Incidence of bleeding complications

    Time frame: 4 days

  2. Model to predict bleeding complications

    Time frame: 4 days

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

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Herning Hospital

Other

Collaborators

  • The Medical Research Fund of the County of Ringkøbing

Registry information

Acronym: OPKAT

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 29, 2005
Registry last updated
Jun 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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