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New treatment option for Stroke, Ischemic
Official title Early Prophylactic Decompressive Hemicraniectomy Following Endovascular Therapy in Large Hemispheric Infarct Trial
ClinicalTrials.gov ID: NCT07118345
What this study is testing
- What it's testing
- Early Decompressive Hemicraniectomy for High-Risk Large Ischemic Core Stroke Post-EVTAcute Ischemic Stroke (AIS), particularly Anterior Circulation Large Vessel Occlusion (LVO), is a major cause of global disability and death. While endovascular thrombectomy (EVT) is the standard first-line treatment for LVO, outcomes remain poor in patients with large ischemic cores (ASPECTS ≤5).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Premorbid mRS ≤1;
- Time from symptom onset to puncture ≤24 hours; including wake-up stroke and unwitnessed stroke. The time at which symptoms began was defined as the...
- ASPECTS 3-5 and NIHSS ≥ 30;
- ASPECTS 0-2; 7.Signs on CT/MRI of an infarct of at least 50% of the middle cerebral artery territory; 8.No midline shift or midline shift \<5mm...
You likely can't join if
- Clinical Exclusion Criteria
- Any symptoms and signs of brain herniation before randomization, such as pupil anisocoria and unstable vital signs.
- In the judgment of the investigator, the subject is likely to have supportive care withdrawn in the first day.
- Commitment to decompressive hemicraniectomy (DHC) prior to enrollment.
- Severe, sustained hypertension (systolic blood pressure \> 220 mm Hg or diastolic blood pressure \> 110 mm Hg);
- Baseline blood glucose \ 400 mg/dl (22.2 mmol/L);
See the full eligibility criteria
- Premorbid mRS ≤1;
- Time from symptom onset to puncture ≤24 hours; including wake-up stroke and unwitnessed stroke. The time at which symptoms began was defined as the "Last Known Well" (LKW). 3.18 to 75 years of age; 4.Internal carotid...
- ASPECTS 3-5 and NIHSS ≥ 30;
- ASPECTS 0-2; 7.Signs on CT/MRI of an infarct of at least 50% of the middle cerebral artery territory; 8.No midline shift or midline shift \<5mm; 9.Mechanical Thrombectomy and successful recanalization (defined as eTICI...
- Clinical Exclusion Criteria
- Any symptoms and signs of brain herniation before randomization, such as pupil anisocoria and unstable vital signs.
- In the judgment of the investigator, the subject is likely to have supportive care withdrawn in the first day.
- Commitment to decompressive hemicraniectomy (DHC) prior to enrollment.
- Severe, sustained hypertension (systolic blood pressure \> 220 mm Hg or diastolic blood pressure \> 110 mm Hg);
- Baseline blood glucose \ 400 mg/dl (22.2 mmol/L);
- Baseline platelet count \<100 x10\^9/L;
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with international normalized ratio \> 1.7;
- Severe renal insufficiency, defined as serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate [GFR] \< 30 ml/min, or patients requiring hemodialysis or peritoneal dialysis;
- Patients that cannot complete 90-day follow-up (such as no fixed residence, overseas patients, etc.);
- Suspected vasculitis or septic embolism;
- Neurological diseases or mental disorders before onset that affect the assessment of the condition;
- Females who are pregnant or in lactation;
- Participating in other clinical trials that could confound the evaluation of the study;
- people who, in the opinion of the investigator, have a life expectancy \<3 months due to conditions not related to current LHI or are unlikely to comply with follow-up requirements. Other conditions that the...
- Evidence of other brain diseases such as cerebral trauma, intracranial tumor (except small meningioma), cerebral aneurysm, etc.
- Evidence of acute ischemic infarction in bilateral anterior circulation territory or involvement of posterior circulation territories (other than in patients with a fetal or near-fetal PCA configuration);
- Vascular perforation during thrombectomy;
- The pre-randomization CT findings exhibits evidence of parenchymal hemorrhage 2 intracranial hemorrhage, diffuse severe subarachnoid hemorrhage, or intraventricular hemorrhage. Patients with localized mild subarachnoid...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.