Treatment with a higher, prophylactic dose of nadroparine to improve outcome after a brain hemorrhage.

Phase 1

• Conditions: Patients suffering from an aneurysmal subarachnoid hemorrhage.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-000790-79-NL
• Lead Sponsor: Academic Medical Centre Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 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. ;Primary end point(s): Mortality;Timepoint(s) of evaluation of this end point: 30 days after initial hemorrhage

Secondary Outcome Measures

Name	Time	Method
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.;Timepoint(s) of evaluation of this end point: 6 months after initial hemorrhage.