Gastrointestinal Decompression in Stroke
EAGER-ASSIST
Safety and Efficacy of Early Gastrointestinal Decompression for Patients With Acute Severe Ischemic Stroke
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Acute severe ischemic stroke is a life-threatening subtype of stroke. Due to stress ulcer and gastric reflux in acute stage, patients with severe ischemic stroke are always complicated with stomach bleeding and pulmonary infections, resulting in poor prognosis and even death. Reducing stomach acidity and avoiding gastric reflux play a pivotal role on controlling serious complications after austere ischemic attack. Gastrointestinal decompression is an cheap, safe, effective and acknowledgemented strategy for treating stomach bleeding and preventing gastric reflux in clinical settings. Early gastrointestinal decompression seems to be an available method to reduce stomach acidity and avoid gastric reflux after severe ischemic stroke. Therefore, we aimed to evaluate the safety and efficacy of early gastrointestinal decompression in patients with acute severe ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Feb 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2024
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJanuary 22, 2024
January 1, 2024
1 year
January 10, 2024
January 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
90-day Death
Death rate at 90 days
90 days
Secondary Outcomes (4)
90-day mRS
90 days
90-day Barthel scores
90 days
30-day mRS
30 days
30-day Barthel scores
30 days
Study Arms (2)
Gastrointestinal decompression group
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
Gastric tube is inserted within 24-hour severe ischemic stroke attack; gastrointestinal decompression is performed for 48 hours.
Eligibility Criteria
You may qualify if:
- Age 18-80 years
- severe AIS, including NIHSS score\>20 in dominant hemisphere infarction, or NIHSS score\>15 in non-dominant hemisphere infarction, or NIHSS consciousness score \>1; · massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery territory and/or the cerebellum territory presented in admitted computed tomography (CT) or MRI
- onset-to-needle time within 24 hours
- prestroke modified Ranking scales (mRS)≤1
- sign the informed consent.
You may not qualify if:
- Recent respiratory infection and/or gastrointestinal bleeding
- austere diseases such as tumors and dyscrasia
- intention to undergo emergency thrombectomy
- pregnant women or nursing mother
- contraindication for gastric tubes
- participating in other clinical trials within previous 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
January 10, 2024
First Posted
January 19, 2024
Study Start
February 1, 2024
Primary Completion
February 1, 2025
Study Completion
July 1, 2025
Last Updated
January 22, 2024
Record last verified: 2024-01