Earlier Mobilization Post Acute Thrombectomy

NCT ID: NCT04153955

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase III trial trying to determine whether 12-hour bed rest following thrombectomy 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Stroke, Acute Stroke, Ischemic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors blind to the subject's treatment/arm will do the evaluations at 90 days

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

12-Hour Bed Rest

Subjects will be mobilized 12 hours after undergoing thrombectomy per usual care

Group Type EXPERIMENTAL

Mobilization

Intervention Type BEHAVIORAL

Any movement out of bed

24-Hour Bed Rest

Subjects will be mobilized 24 hours after undergoing thrombectomy per usual care

Group Type ACTIVE_COMPARATOR

Mobilization

Intervention Type BEHAVIORAL

Any movement out of bed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mobilization

Any movement out of bed

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 years or older
* Received thrombectomy (may have also received intravenous tPA) for a diagnosis of acute ischemic stroke
* TICI 2b/2c/3 score following thromectomy
* Patient and/or Legally Authorized Representative provide consent

Exclusion Criteria

* TICI 0/1/2a score following thrombectomy
* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brian Silver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brian Silver

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brian Silver, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H00018239

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.