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

Ischemic Stroke Clinical Trial

— EMISTPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331200
• Other study ID #: 10-007822
• Status: Completed
• Phase: N/A
• First received: February 4, 2011
• Last updated: February 25, 2013
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
United States	Mayo Clinic Hospital	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Patient Disability post-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.	30-days post-IV tPA infusion	No