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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01331200
First received: February 4, 2011
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition
Ischemic Stroke

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-tPA Infusion.

Resource links provided by NLM:

Drug Information available for: Alteplase
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Level of Patient Disability post-TPA Infusion. [ Time Frame: 30-days post-IV tPA infusion ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients experiencing 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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331200

Locations
United States, Florida
Mayo Clinic Hospital
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Scott M Arnold, PT Mayo Clinic Florida
Principal Investigator: Olivia S Chavez, MS, OTR/L Mayo Clinic Florida
Principal Investigator: William D Freeman, MD Mayo Clinic Florida
Principal Investigator: James Meschia, MD Mayo Clinic Florida
Principal Investigator: Lesia Mooney, RN Mayo Clinic Florida
  More Information

No publications provided

Responsible Party: Scott Arnold, PT, Mayo Clinic Florida
ClinicalTrials.gov Identifier: NCT01331200     History of Changes
Other Study ID Numbers: 10-007822
Study First Received: February 4, 2011
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
ischemic stroke
tissue plasminogen activator
early mobilization
patient safety
length of stay

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
 Brain Ischemia
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013