Coronary Arteriosclerosis, Myocardial Ischemia
Conditions
Keywords
Coronary angiography, Complications, Observation
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.
Interventions
BEHAVIORALMoving
The patients are allowed to lift their head, arms and legs during the 2 hours.
BEHAVIORALNo 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
The Medical Research Fund of the County of Ringkøbing
Herning Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Countries
Denmark
Outcome results
None listed