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

NCT01331200 | Completed DMC

• 1 other identifier: 10-007822
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients post acute ischemic stroke that have been treated with intravenous tissue plasminogen activator (IV-tPA)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Hospital

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Scott M Arnold, PT

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Olivia S Chavez, MS, OTR/L

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• William D Freeman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• James Meschia, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Lesia Mooney, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: April 7, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (1)