To test the safety and preliminary efficacy of a dual acute thrombolytic treatment consisting of a small intravenous (IV) bolus of alteplase followed by IV infusion of HisproUK against usual treatment with IV alteplase in patients presenting with…
ID
Bron
Verkorte titel
Aandoening
Stroke, Ischemic stroke, Thrombolytic therapy, Treatment
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is any post-intervention intracranial haemorrhage on MRI according to the Heidelberg Bleeding Classification within 24-48 hours of study drug administration.
Achtergrond van het onderzoek
Randomized controlled phase II trial to test the safety and preliminary efficacy of a dual thrombolytic treatment consisting of a small intravenous (IV) bolus of alteplase followed by IV infusion of mutant pro-urokianse against usual treatment with IV alteplase in patients presenting with ischemic stroke.
Doel van het onderzoek
To test the safety and preliminary efficacy of a dual acute thrombolytic treatment consisting of a small intravenous (IV) bolus of alteplase followed by IV infusion of HisproUK against usual treatment with IV alteplase in patients presenting with ischemic stroke
Onderzoeksopzet
30 day follow-up
Onderzoeksproduct en/of interventie
Bolus of IV alteplase (5 mg) followed by continuous infusion of HisproUK 40 mg/hr during 60 minutes. Depending on results of interim analyses, the alternate dose may be revised to a lower dose (30mg/hr during 60 minutes) or a higher dose (50mg/hr during 60 minutes).
Publiek
DUMAS trial office
Rotterdam 3000 CA
The Netherlands
0639583967
dumas@erasmusmc.nl
Wetenschappelijk
DUMAS trial office
Rotterdam 3000 CA
The Netherlands
0639583967
dumas@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- A clinical diagnosis of ischemic stroke;
- A score of at least 1 on the NIH Stroke Scale;
- CT ruling out intracranial hemorrhage;
- Treatment possible within 4.5 hours from symptom onset or last seen well;
- Meet the criteria for standard treatment for IV alteplase according to national guidelines;
- Age of 18 years or older;
- Written informed consent (deferred).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Candidate for endovascular thrombectomy (i.e., a proximal intracranial large artery occlusion on CTA);
- Contra-indication for standard treatment with IV alteplase according to national guidelines;
- Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2;
- Known pregnancy;
- Participation in any medical or surgical intervention trial other than current.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7409 |
| NTR-old | NTR7634 |
| Ander register | METC Erasmus MC : 2018-00448-42 EudraCT |