Observation and Prediction of Complications After Coronary Angiography (OPKAT)
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|ClinicalTrials.gov Identifier: NCT00259194|
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : June 11, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Arteriosclerosis Myocardial Ischemia||Behavioral: Moving Behavioral: No Moving||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Observation and Prediction of Complications After Coronary Angiography|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|