Observation and Prediction of Complications After Coronary Angiography

Not Applicable

Completed

• Conditions: Coronary Arteriosclerosis; Myocardial Ischemia
• Interventions: Behavioral: Moving; Behavioral: No Moving

• Registration Number: NCT00259194
• Lead Sponsor: Herning Hospital

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:

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-11-29
• Study Start: 2005-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-08
• Last Update Posted: 2009-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alternative Observation	Moving	Moving in bed during observation after coronary angiography
Standard Observation	No Moving	No moving in bed during observation after coronary angiography

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Coronary Angiography Laboratory; 🇩🇰 Herning, Denmark

Dept. of Med., Sect. of Cardology, Herning Hospital; 🇩🇰 Herning, Denmark