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| Name | Class |
|---|---|
| The Medical Research Fund of the County of Ringkøbing | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternative Observation | Active Comparator | Moving in bed during observation after coronary angiography |
|
| Standard Observation | Experimental | No moving in bed during observation after coronary angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moving | Behavioral | The patients are allowed to lift their head, arms and legs during the 2 hours. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ole May, Dr.,Ph.D. | Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coronary Angiography Laboratory | Herning | 7400 | Denmark | |||
| Dept. of Med., Sect. of Cardology, Herning Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19245381 | Result | May O, Schlosser H, Skytte L. A high blood pressure predicts bleeding complications and a longer hospital stay after elective coronary angiography using the femoral approach. J Interv Cardiol. 2009 Apr;22(2):175-8. doi: 10.1111/j.1540-8183.2009.00427.x. Epub 2009 Feb 24. | |
| 18513345 | Result | May O, Schlosser H, Skytte L. A randomized trial assessing the influence of lying still or being allowed to move in the observation period following coronary angiography using the femoral approach. J Interv Cardiol. 2008 Aug;21(4):347-9. doi: 10.1111/j.1540-8183.2008.00359.x. Epub 2008 May 29. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| No Moving | Behavioral | 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. |
|
| Herning |
| 7400 |
| Denmark |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |