SuspendedNot Applicable

Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke

Stopped: Funding issues from sponsors

China356 participantsStarted 2022-01-14

Plain-language summary

Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). A recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, the investigator argues that DELP may exert neuroprotective effect on acute cerebral hemorrhage (ACH). In this context, the prospective, random, open-label, blind-endpoint, multi-centre study is designed.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 18-80; * Spontaneous cerebral hemorrhage; * Deep supratentorial intracerebral hemorrhage (basal ganglia) with hematoma volume 5-40ml, or supratentorial lobar hemorrhages with hematoma volume 5-30ml; * NIHSS: 6-20; * Time from onset to DELP: 6-48 hours; * Premorbid mRS 0 or 1; * Signed informed consent; Exclusion Criteria: * Secondary cerebral hemorrhage (secondary to trauma, tumor, vascular malformation, hemorrhage transformation of ischemic stroke, etc.); * Comatose patients on admission (GCS score 3-8 on the Glasgow Coma Scale); * Patients with intracerebral hemorrhage ruptured into the ventricle, which should be treated by surgery; * Planed surgery; * Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; * Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg), or hypotension (systolic blood pressure below 90mmHg or diastolic blood pressure below 60 mmHg); * Previous allergy to heparin or calcium; * Life expectancy is less than 6 months due to comorbidity * Infected at the venipuncture site * hypoproteinemia; * Unsuitable for this clinical studies assessed by researcher.

What they're measuring

Proportion of patients with modified Rankin Score 0 to 2

Timeframe: Day 90

Trial details

NCT IDNCT05128513

SponsorGeneral Hospital of Shenyang Military Region

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-08