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Completed

NCT Number: NCT01331200

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Hospital

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)

Treatment and study plan

Primary outcomes

  1. Level of Patient Disability post-TPA Infusion.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-tPA Infusion.

Acronym: EMISTPA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 7, 2011
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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