Gastrointestinal Decompression in Stroke (EAGER-ASSIST)

Tianjin Medical University

Status: Not yet enrolling

Conditions: Stroke; Stomach Acidity; Pulmonary Infection; Gastrointestinal Decompression

Treatments: Procedure: Gastrointestinal decompression; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06214091

EAGER-ASSIST-1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Gastrointestinal decompression group

Experimental group

Treatment:

Procedure: Gastrointestinal decompression

Control group

Placebo Comparator group

Treatment:

Procedure: Control