E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suffering from an aneurysmal subarachnoid hemorrhage. |
|
E.1.1.1 | Medical condition in easily understood language |
Brain hemorrhage caused by rupture of an aneurysm of a brain artery. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate if treatment with therapeutic dose nadroparine, compared to standard used prophylactic dose, in aSAH patients whose causative aneurysms have been treated endovascularly with coiling, has a favorable effect on mortality within 30 days after initial bleeding. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate whether patients treated with therapeutic LMWH show a difference in delayed cerebral ischemia, (hemorrhagic) complications during admission, hydrocephalus, non-home discharge location, quality of life, serum hemostatic and inflammatory parameters, cognitive functioning at three and six months, healthcare costst and clinical outcome at six months. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or DSA • Coiling of the causative aneurysm within 72 hours of initial SAH • Informed consent within 24 hours after coiling • Adult age (≥18 years)
|
|
E.4 | Principal exclusion criteria |
• Stent-assisted coiling • Contra-indications for LMWH: History of heparin-induced thrombocytopenia, Active bleeding, Known hemorrhagic diathesis due to coagulation disorders (with the exception of dis-seminated intravascular coagulation), Severe hypertension: uncontrolled hypertension with a MAP > 135mmHg, History of hypertensive or diabetic retinopathy, Active infectious endocarditis, Severe renal impairment (creatinine clearance <30 mL / min) • No proficiency of Dutch or English language • No informed consent
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days after initial hemorrhage |
|
E.5.2 | Secondary end point(s) |
Clinical outcome, discharge location, presence and severity of delayed cerebral ischemia, hemorrhagic complications, coagulation profile, inflamatory profile, endothelial activation, hydrocephalus, other SAH related complications. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months after initial hemorrhage. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Lower dose of same medicinal product |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |