Gastrointestinal Decompression in Stroke

NCT ID: NCT06214091

Last Updated: 2024-01-22

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Stomach Acidity Pulmonary Infection Gastrointestinal Decompression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Gastrointestinal decompression group

Group Type EXPERIMENTAL

Gastrointestinal decompression

Intervention Type PROCEDURE

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

Control group

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

Gastric tube is inserted within 24-hour severe ischemic stroke attack.

Interventions

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Gastrointestinal decompression

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

Intervention Type PROCEDURE

Control

Gastric tube is inserted within 24-hour severe ischemic stroke attack.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiayue Ding

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jiayue Ding

Role: CONTACT

+8618518347837

Other Identifiers

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EAGER-ASSIST-1

Identifier Type: -

Identifier Source: org_study_id

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