Observation and Prediction of Complications After Coronary Angiography

Study Overview
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Brief Summary
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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: 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 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.

Official Title
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Observation and Prediction of Complications After Coronary Angiography

Conditions
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Coronary Arteriosclerosis, Myocardial Ischemia

Intervention / Treatment
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* Behavioral: Moving
* Behavioral: No Moving


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary angiography, Complications, Observation