Earlier Mobilization Post Acute Thrombolysis

NCT04153942 | Withdrawn Phase 3 DMC

• 1 other identifier: H00018238
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase III trial trying to determine whether 12-hour bed rest following IV thrombolysis therapy (i.e. tPA) for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic

Keywords

Mobilization; Thrombolysis; Ischemia; Cerebrovascular Disorders; Brain Diseases; Recovery

Outcome Measures

Primary Outcomes (1)

• 90 day mRS

  Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being best outcome) of 0-2 at 90 days

  90 days post bed rest

Secondary Outcomes (5)

• Pneumonia

  Duration of hospitalization stay, average 5 days

• Venous Thromboembolism

  Duration of hospitalization stay, average 5 days

• Neurological Worsening

  Duration of hospitalization stay, average 5 days

• Readmission

  90 days post bed rest

• Length of Stay

  Duration of hospitalization stay, average 5 days

Study Arms (2)

12-Hour Bed Rest

EXPERIMENTAL

Subjects will be mobilized 12 hours after receiving IV thrombolysis therapy per usual care

Behavioral: Mobilization

24-Hour Bed Rest

ACTIVE COMPARATOR

Subjects will be mobilized 24 hours after receiving IV thrombolysis therapy per usual care

Behavioral: Mobilization

Interventions

Mobilization BEHAVIORAL

Any movement out of bed

12-Hour Bed Rest; 24-Hour Bed Rest

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Received intravenous tPA for a clinical diagnosis of acute ischemic stroke
• Patient and/or Legally Authorized Representative provide consent

You may not qualify if:

• Venous thromboembolism present at symptom onset
• Pneumonia present at symptom onset
• STEMI at symptom onset
• Positive troponins at symptom onset according to local values
• Bone fracture at symptom onset
• Treatment includes or anticipated to include thrombectomy
• Intubation anticipated or occurred
• Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more accompanied by PH2 hemorrhage on imaging) at the time of screening.
• Pre-screening systolic blood pressure \< 110 mmHg
• Resting pulse oximetry \< 92% (with or without supplemental oxygen)
• Neurological worsening (defined as NIHSS increase of 4 points compared to initial score) prior to screening.
• Baseline modified Rankin Scale score \> 2
• Known pregnancy
• Patient not anticipated to survive 3 months
• Patient not anticipated to follow-up at 3 months

Sponsors & Collaborators

• Brian Silver: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Ischemia; Cerebrovascular Disorders; Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian Silver, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors blind to the subject's treatment/arm will do the evaluations at 90 days
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: November 6, 2019
• Study Start: August 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share