Hemoadsorption for Severe Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Wannan Medical College
About this trial
This is a multicenter, randomized-controlled, open-label, blinded endpoint clinical trial that aims to evaluate the efficacy and safety of hemoadsorption for severe ischemic stroke
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
15≤ NIHSS score ≤32;
3<GCS score ≤12;
CT hypodensity area >1/2 of the MCA territory; 4.hs-CRP ≥2 mg/L at randomization; 5.If reperfusion therapy is performed, no improvement in NIHSS score (still ≤32) post-treatment; 6.Signed informed consent obtained.
Disqualifiers
Hemorrhagic transformation of PH2 type prior to randomization;
Brain herniation or decompressive craniectomy performed before randomization;
Hemodynamic instability refractory to medical correction (systolic blood pressure <70 mmHg or diastolic blood pressure <50 mmHg) or decompensated heart failure (NYHA Class III or IV);
Severe hepatic impairment (defined as ALT >2 times the upper limit of normal or AST >2 times the upper limit of normal) and renal impairment (defined as serum creatinine >1.5 times the upper limit of normal or estimated glomerular filtration rate [eGFR] <50 mL/min);
Trial design
Design model
Parallel
Treatments tested in this trial
Hemoadsorption
Procedure/SurgeryPatients in intervention group will receive standard treatment plus hemoadsorption therapy administered once on days 1, 3, and 5 following enrollment.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: standard treatment groupNo intervention 0 interventions
Group B: standard treatment plus hemoadsorption groupOther 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of severe adverse functional outcomes (modified Rankin Scale [mRS] 4-6)
Time frame
From enrollment to the end of treatment at 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Wannan Medical College
Lead sponsor
Anqing Municipal Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
Baotou Central Hospital
Collaborator
The NO.1 People's Hospital of Shizuishan
Collaborator
Fuyang people's hospital
Collaborator
Second People's Hospital of Hefei City
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
THE SECOND PEOPLE'S HOSPITAL, WUHU
Collaborator
Source ClinicalTrials.gov