Earlier Mobilization Post Acute Thrombolysis | NCT04153942

Studies
Earlier Mobilization Post Acute Thrombolysis

NCT04153942

Sponsor

Brian Silver

Status

Withdrawn

Last Update Posted

Oct 30, 2023Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Stroke
Stroke, Acute
Stroke, Ischemic

Interventions

Mobilization

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never started/initiated.

Expanded Access Info

Start Date

Aug 2023Estimated

Primary Completion Date

Jul 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Oct 21, 2019

First Submission Date that Met QC Criteria

Nov 4, 2019

First Posted Date

Nov 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2023

Last Update Posted Date

Oct 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Mobilization	Behavioral	Any movement out of bed	12-Hour Bed Rest 24-Hour Bed Rest

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pneumonia	Determine whether rates of pneumonia are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.	Duration of hospitalization stay, average 5 days
Venous Thromboembolism

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Brian Silver, MD	UMass Medical School	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke
D007511	Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Ancestor Terms

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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