Observation and Prediction of Complications After Coronary Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-12-31

Brief Summary

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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:

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.

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Detailed Description

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Conditions

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Coronary Arteriosclerosis Myocardial Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Alternative Observation

Moving in bed during observation after coronary angiography

Group Type ACTIVE_COMPARATOR

Moving

Intervention Type BEHAVIORAL

The patients are allowed to lift their head, arms and legs during the 2 hours.

Standard Observation

No moving in bed during observation after coronary angiography

Group Type EXPERIMENTAL

No Moving

Intervention Type 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.

Interventions

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Moving

The patients are allowed to lift their head, arms and legs during the 2 hours.

Intervention Type BEHAVIORAL

No Moving

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No