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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01331200

Acronym

EMISTPA

Enrollment

Registered

2011-04-07

Start date

2011-01-31

Completion date

2012-11-30

Last updated

2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

ischemic stroke, tissue plasminogen activator, early mobilization, patient safety, length of stay

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results