Immediate Mobilization After Cardiac Catheterisation

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). At the same time the investigators will investigate whether it reduces the discomfort being mobilized immediately after the procedure.

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Detailed Description

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The frequency of hematoma, bleeding or pseudoaneurysm at the access site in the groin is 7-15% with regimens that involve 0-2 hours of bed rest, somewhat more frequent after Percutaneous coronary intervention (PCI) than coronary angiography (CAG). There seems to be no reduction in the complications of the CAG or PCI by maintaining the bed rest for more than 2 hours after the procedure. Angio-Seal seems most effective of current closure devices. There is less discomfort associated with early compared with late mobilization. Protamine reverse heparin's effect without the side effects of that regime.

There lacks a larger randomized study of the safety of mobilizing patients immediately after CAG and after PCI.

Conditions

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Vascular Access Complication Comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Immediate mobilization

Immediate mobilization after coronary angiography or percutaneous coronary intervention

Group Type EXPERIMENTAL

Immediate mobilization

Intervention Type OTHER

Patients are mobilized immediate after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device. Heparin reverted with Protaminsulphate

Two hours bedrest

Bedrest two hours after coronary angiography or percutaneous coronary intervention

Group Type ACTIVE_COMPARATOR

Two hours bedrest

Intervention Type OTHER

Patients is following the usual regimen, two hours bedrest after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device before mobilization. Heparin is reverted with Protaminsulphate

Interventions

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Immediate mobilization

Patients are mobilized immediate after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device. Heparin reverted with Protaminsulphate

Intervention Type OTHER

Two hours bedrest

Patients is following the usual regimen, two hours bedrest after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device before mobilization. Heparin is reverted with Protaminsulphate

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* CAG or PCI performed via the femoral artery
* No hematoma in the groin (\> 5 cm in diameter)
* Heparin reversed with protamine after PCI

Exclusion Criteria

* Oozing, bleeding or hematoma
* Treatment with Integrilin, ReoPro, or Marevan
* Heparin can not be reversed
* The patient does not want to participate
* Systolic blood pressure \> 180 mm Hg after the procedure
* BMI\> 35 (can be modified if the groin can be assessed in an upright position)
* Demented, unconscious patients who do not understand the information for participants.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No