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Impact of Post-Reperfusion Position Management on Prognosis in Patients with Acute Large Core Infarction: A Multicenter, Open-Label, Blinded-Endpoint, Randomized Controlled Trial

Impact of Post-Reperfusion Position Management on Prognosis in Patients with Acute Large Core Infarction: A Multicenter, Open-Label, Blinded-Endpoint, Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103000
Enrollment
Unknown
Registered
2025-05-22
Start date
2025-09-19
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Interventions

30° Head Elevation:30° Head Elevation
0-10° Supine Position: 0-10° Supine Position

Sponsors

Baotou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2.Time from symptom onset to randomization =6; 5. ASPECTS <6 core ; 6. Underwent endovascular therapy achieving eTICI 2b-3 reperfusion; 7. Written informed consent obtained from patient or legal guardian.

Exclusion criteria

Exclusion criteria: 1.Pregnancy or lactation confirmed, or positive pregnancy test prior to randomization; 2. Documented severe contrast allergy (excluding mild rash reactions); 3. Refractory hypertension uncontrolled by medication (persistent SBP >185 mmHg or DBP >110 mmHg); Note: Patients may be enrolled if antihypertensives successfully maintain BP within acceptable thresholds; 4. Hemorrhagic diathesis meeting any criteria: Platelet count =35 seconds; Warfarin use with INR >1.7;Direct thrombin/Xa inhibitor use within 48h (apixaban, rivaroxaban, dabigatran, etc.);Exception: No routine coagulation testing required for patients without coagulopathy history/suspicion. 5. Major organ surgery/biopsy within past 1 month; 6. Active bleeding (e.g., gastrointestinal, genitourinary) within past 1 month; 7. Current hemodialysis/peritoneal dialysis; severe renal insufficiency (GFR 220 µmol/L) 8. History of intracranial/subarachnoid hemorrhage or space-occupying brain tumors; 9. Life expectancy <3 months (e.g., advanced malignancy, severe cardiopulmonary disease); 10. Concurrent enrollment in other interventional trials affecting outcome assessment; 11. Investigator-determined ineligibility (e.g., psychiatric/cognitive impairments compromising protocol adherence); 12. Radiological evidence of midline shift/heralding cerebral herniation signs; 13. Intracranial hemorrhage confirmed on imaging; 14. Acute bilateral strokes or multivessel occlusion involving multiple territories; 15. Anatomical constraints precluding head elevation protocol.

Design outcomes

Primary

MeasureTime frame
90d mRS ordinal shift;

Secondary

MeasureTime frame
The proportion of 90-day mRS Scores 0-2;The proportion of 90-day mRS Scores 0-3;Proportion of subjects with NIHSS reduction >=4 points at D7/discharge;Incidence of aspiration pneumonia within 72 hours;Incidence of symptomatic intracranial hemorrhage within 36 hours;All-cause mortality at 90days;Probability of any intracranial hemorrhage within 36 hours ;Rate of decompressive craniectomy during hospitalization;

Countries

China

Contacts

Public ContactChangchun Jiang

Baotou Central Hospital

13347180510@163.com+86 133 4718 0510

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026