Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT00259194
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2005-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observation and Prediction of Complications After Coronary Angiography
Sponsor:
Herning Hospital
Organization:
Study Overview
Official Title:
Observation and Prediction of Complications After Coronary Angiography
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPKAT
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: