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Observation and Prediction of Complications After Coronary Angiography

NCT00259194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2009-06-11

No results posted yet for this study

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:

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.

Conditions

  • Coronary Arteriosclerosis
  • Myocardial Ischemia

Interventions

BEHAVIORAL

Moving

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

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.

Sponsors & Collaborators

  • The Medical Research Fund of the County of Ringkøbing

    collaborator UNKNOWN

  • Herning Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00259194 on ClinicalTrials.gov