Observation and Prediction of Complications After Coronary Angiography (OPKAT)

Herning Hospital

Status: Completed

Conditions: Myocardial Ischemia; Coronary Arteriosclerosis

Treatments: Behavioral: Moving; Behavioral: No Moving

Study type: Interventional

Funder types: Other

Identifiers

NCT00259194

OPKAT

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Alternative Observation

Active Comparator group

Description:

Moving in bed during observation after coronary angiography

Treatment:

Behavioral: Moving

Standard Observation

Experimental group

Description:

No moving in bed during observation after coronary angiography

Treatment:

Behavioral: No Moving