StrokeEAGER-ASSISTNCT06214091
Gastrointestinal Decompression in Stroke
A study testing Gastrointestinal decompression in people with Stroke and Stomach Acidity, run by Tianjin Medical University General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Stomach Acidity, Pulmonary Infection
- What is being tested?
- Gastrointestinal decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Early Gastrointestinal Decompression for Patients With Acute Severe Ischemic Stroke
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.
- Being tested
- Gastrointestinal decompression, Control
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrointestinal decompressionProcedure or surgery
Gastric tube is inserted within 24-hour severe ischemic stroke attack; gastrointestinal decompression is performed for 48 hours.
ControlProcedure or surgery
Gastric tube is inserted within 24-hour severe ischemic stroke attack.
| Study group | Role | What they receive |
|---|---|---|
| Gastrointestinal decompression group | Experimental | Not described Receives: Procedure: Gastrointestinal decompression |
| Control group | Placebo comparator | Not described Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Death
Death rate at 90 days
Measured: 90 days
Secondary outcomes (4)
90-day mRS
mRS at 90 days
Measured: 90 days
90-day Barthel scores
Barthel scores at 90 days
Measured: 90 days
30-day mRS
mRS at 30 days
Measured: 30 days
30-day Barthel scores
Barthel scores at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayue Ding, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214091
- Sponsor's protocol ID
- EAGER-ASSIST-1
- Acronym
- EAGER-ASSIST
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Early Gastrointestinal Decompression for Patients With Acute Severe Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06214091
- Acronym / sponsor ID
- EAGER-ASSIST / EAGER-ASSIST-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrointestinal decompression group | Experimental | Procedure: Gastrointestinal decompression |
| Control group | Placebo comparator | Procedure: Control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrointestinal decompressionGastric tube is inserted within 24-hour severe ischemic stroke attack; gastrointestinal decompression is performed for 48 hours. | Procedure or surgery | Gastrointestinal decompression group |
| ControlGastric tube is inserted within 24-hour severe ischemic stroke attack. | Procedure or surgery | Control group |
Primary outcome
90-day Death
Time frame: 90 days
Death rate at 90 days
4 secondary outcomes
90-day mRS
Time frame: 90 days
90-day Barthel scores
Time frame: 90 days
30-day mRS
Time frame: 30 days
30-day Barthel scores
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Gastrointestinal decompression in people with Stroke and Stomach Acidity, run by Tianjin Medical University General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayue Ding (+8618518347837, sjnkzz2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day Death (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.