Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259194
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2005-11-28
Brief Title:
Observation and Prediction of Complications After Coronary Angiography
Sponsor:
Herning Hospital
Organization:
Herning Hospital
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 avoidreduce 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:
None
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?:
None