Gastrointestinal Decompression in Stroke

Stroke Clinical Trial

— EAGER-ASSIST  

Official title:

Safety and Efficacy of Early Gastrointestinal Decompression for Patients With Acute Severe Ischemic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06214091
• Other study ID #: EAGER-ASSIST-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2024
• Source: Tianjin Medical University General Hospital
• Contact: Jiayue Ding
• Phone: +8618518347837
• Email: sjnkzz2[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Infection
• Stroke

Intervention

Procedure:
• Gastrointestinal decompression
Gastric tube is inserted within 24-hour severe ischemic stroke attack; gastrointestinal decompression is performed for 48 hours.
• Control
Gastric tube is inserted within 24-hour severe ischemic stroke attack.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day Death	Death rate at 90 days	90 days
Secondary	90-day mRS	mRS at 90 days	90 days
Secondary	90-day Barthel scores	Barthel scores at 90 days	90 days
Secondary	30-day mRS	mRS at 30 days	30 days
Secondary	30-day Barthel scores	Barthel scores at 30 days	30 days