Observation and Prediction of Complications After Coronary Angiography (OPKAT)
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.
|Coronary Arteriosclerosis Myocardial Ischemia||Behavioral: Moving Behavioral: No Moving|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Observation and Prediction of Complications After Coronary Angiography|
- Incidence of bleeding complications [ Time Frame: 4 days ]
- Model to predict bleeding complications [ Time Frame: 4 days ]
- Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications [ Time Frame: 4 days ]
|Study Start Date:||December 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: Alternative Observation
Moving in bed during observation after coronary angiography
The patients are allowed to lift their head, arms and legs during the 2 hours.
Experimental: Standard Observation
No moving in bed during observation after coronary angiography
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259194
|Coronary Angiography Laboratory|
|Herning, Denmark, 7400|
|Dept. of Med., Sect. of Cardology, Herning Hospital|
|Herning, Denmark, 7400|
|Study Chair:||Ole May, Dr.,Ph.D.||Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning|