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 min. and the patient is in our department observed in bed for 2 hours. We 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 randomised 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

   1. Frequency of hematoma (>5 cm)
   2. Frequency of pseudoaneurysms
   3. Frequency of bleeding demanding surgery
   4. 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

Condition	Intervention
Coronary Arteriosclerosis Myocardial Ischemia	Behavior: Moving in bed during observation after angiography.

Further study details as provided by Herning Hospital:

Primary Outcomes: 1. Incidence of bleeding complications the first 4 days after angiography; 2. Model to predict bleeding complications; 3. Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications
Expected Total Enrollment:  1000

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Coronary angiography by the femoral access, where the arterial lumen is reached.
2. Only attempted puncture at one side.
3. Age >= 18 years

Exclusion Criteria:

1. Conditions that makes observation in the department impossible
2. Dementia or other reasons to expect lack of compliance
3. Previous participation in the project
4. Implanted vascular prothesis at puncture site

Please refer to this study by ClinicalTrials.gov identifier  NCT00259194

Ole May, Dr., Ph.D.      +4599272088/mobil: +4526175575    hecom@ringamt.dk

Denmark
      Dept. of Med., Sect. of Cardology, Herning Hospital, Herning,  7400,  Denmark

Study chairs or principal investigators

Ole May, Dr.,Ph.D.,  Study Chair,  Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning   

Study ID Numbers:  OPKAT
Last Updated:  December 8, 2005
Record first received:  November 28, 2005
ClinicalTrials.gov Identifier:  NCT00259194
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on 2006-01-10