Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-Tissue Plasminogen Activator (IV-tPA)

Completed

• Conditions: Ischemic Stroke

• Registration Number: NCT01331200
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to study the safety and feasibility of mobilization of acute ischemic stroke patients treated with IV-tPA between 12-24 hours of treatment.

Detailed Description

Abstract:

Introduction

Historical precedence exists demonstrating that early intensive care unit (ICU) mobilization of patients reduces risks of complication and lengths of hospital stay, and may improve long-term health status of patients.

Objective

To determine the safety of early mobilization by physical and/or occupational therapy in acute ischemic stroke patients within 24-hours of IV-tPA infusion and to examine if early mobilization leads to shortened ICU and hospital length of stay.

Methods

Prospective study of incidence of adverse response and functional mobility status of study patients mobilized by occupational and/or physical therapy between 12- 24 hours after IV-tPA infusion with comparison of ICU and hospital Length of Stay data between study group and pre-study patients who were mobilized by occupational and/or physical therapy services at no pre-determined time after IV-tPA infusion. Additionally, patients will be contacted by study personnel approximately 3 to 5-days and 30-days post-infusion for completion of Modified Rankin Scale stroke disability survey as follow up of stroke recovery.

Setting

Medical and surgical intensive care units at Mayo Clinic Florida.

Patients

All patients with acute ischemic stroke who receive intravenous tissue plasminogen activator (IV-tPA) infusion, survive to discharge from the hospital, are hemodynamically stable, and are mobilized by physical and/or occupational therapy within 24 hours post-tPA infusion.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-04
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-07
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-25
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients post acute ischemic stroke that have been treated with intravenous tissue plasminogen activator (IV-tPA)
• 13 hours have elapsed since initiation of intravenous TPA infusion
• Patients are hemodynamically stable (e.g., not on vasopressors or antihypertensive drips or requiring multiple IV PRN boluses of either medication)
• Patient is able to actively engage in the evaluation

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Exclusion Criteria

• Patients with femoral sheaths or recent removal of femoral sheaths
• Patients who are hemodynamically unstable, with active bleeding from lines, catheters, INT site or wounds or angioedema
• Electrocardiogram showing (HR>100)
• Vital signs (HR > 100, SBP <90 or >180, DBP <70 or > 105)
• Patients experiencing marked diaphoresis, facial pallor, intense anxious or painful facial expression (especially in aphasic patients)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of Patient Disability post-TPA Infusion.	30-days post-IV tPA infusion	Study participants will be contacted at approximately 3 to 5-days and 30-days post-IV tPA infusion to capture level of disability by use of Modified Rankin Scale.

Trial Locations

Locations (1)

Mayo Clinic Hospital; 🇺🇸 Jacksonville, Florida, United States