Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)

Korábbi kezelés

• Ischemic stroke or myocardial infarction in the previous 30 days.
• Surgery in the previous 30 days, except minor dermatological or gynaecological surgery without anaesthesia and wound healing disorders and patients with thrombectomy.
• Known participation in another clinical trial investigating a drug and/or medical product in the last 7 days before study inclusion.

Más betegség

• Presence of any of the following conditions: Sinus or cerebral venous thrombosis, intracerebral haemorrhage, subarachnoid haemorrhage on qualified imaging (cCT with CT-A or MRI with MR-A). However, petechial haemorrhagic transformations of the index infarct and cerebral microhaemorrhages may be included.
• Active malignant tumour disease in the last 6 months.
• Current known immunosuppression due to immunomodulatory medication with immunosuppressive dose or underlying immunosuppressive disease (e.g. HIV).
• Acute fulminant infectious disease in the last 7 days (fever > 38.5°C or suspected by the Investigator).
• Known allergies or intolerance to dornase alfa (Pulmozyme) or recombinant protein products derived from Chinese hamster ovary cells.

Laborértékek

• Breastfeeding or pregnant woman, women of childbearing age without known use of contraceptives with positive urine or serum beta-human choriogonadotropin test.
• Thrombocytopenia, leukocyte count <1500/μl.
• Severe renal insufficiency with GFR≤29 ml/min/ 1.73m³ and/or renal insufficiency requiring dialysis.

Egyéb

• Estimated or known weight > 100 kg.

• Patients with suspected acute ischemic stroke with symptom onset (last-seen-well) until Investigational drug application of less than 12 hours.
• Consent to participate in the study.
• Age ≥ 18 years.
• NIHSS ≥10 at admission.