Intraventricular infusion of rt-PA in severe intraventricular haemorrhage after aneurysmal subarachnoid haemorrhage. A randomised clinical trial.

2012 ◽  
Author(s):  
D. Nieuwkamp
Keyword(s):  
Clinical Trial ◽  
Subarachnoid Haemorrhage ◽  
Intraventricular Haemorrhage ◽  
Randomised Clinical Trial ◽  
Aneurysmal Subarachnoid Haemorrhage ◽  
Intraventricular Infusion

Erythropoietin in patients with aneurysmal subarachnoid haemorrhage: a double blind randomised clinical trial

2007 ◽  
Vol 149 (11) ◽  
pp. 1089-1101 ◽  
Author(s):  
J. B. Springborg ◽  
C. Møller ◽  
P. Gideon ◽  
O. S. Jørgensen ◽  
M. Juhler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Subarachnoid Haemorrhage ◽  
Randomised Clinical Trial ◽  
Aneurysmal Subarachnoid Haemorrhage ◽  
Double Blind

scholarly journals CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH): study protocol for a randomized controlled phase II clinical trial

2020 ◽  
Author(s):  
Inez Koopman ◽  
Gabriel J.E. Rinkel ◽  
Mervyn D.I. Vergouwen
Keyword(s):  
Clinical Trial ◽  
Brain Injury ◽  
Subarachnoid Haemorrhage ◽  
Phase Ii ◽  
Intervention Group ◽  
Case Fatality ◽  
Phase Ii Clinical Trial ◽  
Aneurysmal Subarachnoid Haemorrhage ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background The inflammatory response after aneurysmal subarachnoid haemorrhage (aSAH) has been associated with early brain injury, delayed cerebral ischemia, poor functional outcome, and case-fatality. In experimental SAH studies, complement C5 antibodies administered shortly after SAH reduced brain injury with approximately 40%. Complement component C5 may be a new therapeutic target to reduce brain injury and hereby improve outcome after aSAH. We aim to investigate the pharmacodynamic efficacy and safety of eculizumab (complement C5 antibody) in patients with aSAH. Methods A randomized, controlled, open-label, phase II clinical trial with blinded outcome assessment. Eculizumab (1200 mg) is administered intravenously <12 hours, on day 3 and on day 7 after ictus. Patients in the intervention group receive prophylactic antibiotics for 4 weeks, and those with a central line or an external ventricular shunt and a positive fungal or yeast culture also receive prophylactic antifungal therapy for 4 weeks. The primary outcome is C5a concentration in cerebrospinal fluid (CSF) on day 3 after ictus. Secondary outcomes include the occurrence of adverse events, inflammatory parameters in blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical- and cognitive outcomes. We aim to evaluate 26 patients with CSF assessments, 13 in the intervention group and 13 in the comparator group. To compensate for early case-fatality and inability to obtain CSF, we will include 20 patients per group. Discussion The CLASH trial is the first trial to investigate the pharmacodynamic efficacy and safety of eculizumab in the early phase after aSAH. Trial registration Netherlands Trial Register: NTR6752, https://www.trialregister.nl/trial/6579. Registered on 27 October 2017. European Clinical Trials Database: EudraCT 2017-004307-51.

scholarly journals CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH): study protocol for a randomised controlled phase II clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Inez Koopman ◽  
◽  
Gabriel J. E. Rinkel ◽  
Mervyn D. I. Vergouwen
Keyword(s):  
Clinical Trial ◽  
Brain Injury ◽  
Subarachnoid Haemorrhage ◽  
Phase Ii ◽  
Intervention Group ◽  
Case Fatality ◽  
Phase Ii Clinical Trial ◽  
Aneurysmal Subarachnoid Haemorrhage ◽  
Efficacy And Safety ◽  
Randomised Controlled

Abstract Background The inflammatory response after aneurysmal subarachnoid haemorrhage (aSAH) has been associated with early brain injury, delayed cerebral ischaemia, poor functional outcome, and case fatality. In experimental SAH studies, complement C5 antibodies administered shortly after SAH reduced brain injury with approximately 40%. Complement component C5 may be a new therapeutic target to reduce brain injury and hereby improve the outcome after aSAH. We aim to investigate the pharmacodynamic efficacy and safety of eculizumab (complement C5 antibody) in patients with aSAH. Methods A randomised, controlled, open-label, phase II clinical trial with blinded outcome assessment. Eculizumab (1200 mg) is administered intravenously < 12 h, on day 3 and on day 7 after ictus. Patients in the intervention group receive prophylactic antibiotics for 4 weeks, and those with a central line or an external ventricular shunt and a positive fungal or yeast culture also receive prophylactic antifungal therapy for 4 weeks. The primary outcome is C5a concentration in the cerebrospinal fluid (CSF) on day 3 after ictus. Secondary outcomes include the occurrence of adverse events, inflammatory parameters in the blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical and cognitive outcomes. We aim to evaluate 26 patients with CSF assessments, 13 in the intervention group and 13 in the comparator group. To compensate for early case fatality and inability to obtain CSF, we will include 20 patients per group. Discussion The CLASH trial is the first trial to investigate the pharmacodynamic efficacy and safety of eculizumab in the early phase after aSAH. Trial registration Netherlands Trial Register NTR6752. Registered on 27 October 2017 European Clinical Trials Database (EudraCT) 2017-004307-51

scholarly journals Computed tomography in the assessment of aneurysmal subarachnoid haemorrhage for clinical outcome: an observational cohort study

2020 ◽  
Author(s):  
David Couret ◽  
Salah Boussen ◽  
Dan Cardoso ◽  
Audrey Alonzo ◽  
Sylvain Madec ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Cohort Study ◽  
Subarachnoid Haemorrhage ◽  
Neurological Outcome ◽  
Area Under The Curve ◽  
Intraventricular Haemorrhage ◽  
Aneurysmal Subarachnoid Haemorrhage ◽  
Acute Hydrocephalus ◽  
Poor Neurological Outcome ◽  
Patients At Risk

Abstract Background: Aneurysmal subarachnoid haemorrhage (aSAH) is a life-threatening event with major complications such as delayed cerebral infarction (DCI) or acute hydrocephalus and poor neurological outcome. DCI occurs most frequently 7 days after aSAH and can last for a prolonged period. The ability to predict these complications would allow the neuro-intensivist to identify patients at risk and select the most appropriate unit for hospitalization. Methods: A 3-year single-centre retrospective cohort study was conducted in our neuroscience critical care unit. Initial computed tomography (CT) scans in patients hospitalized for aSAH were blindly assessed using eight grading systems: the Fisher scale, modified Fisher scale, Barrow Neurological Institute scale, Hijdra scale, Intraventricular Haemorrhage (IVH) score, Graeb score, and LeRoux score. We evaluated and compared these radiological scales for the early prediction of DCI, acute hydrocephalus, and poor neurological outcome at 3 months. Results: Of 200 patients with aSAH who survived to day 7 and were included for DCI analysis, 39% cases were complicated with DCI. The Hijdra scale was the best predictor for DCI, with a receiver operating characteristic area under the curve (ROCAUC) of 0.80 (95% confidence interval [CI], 0.74–0.85). The ideal cut-off score for all patients was 20/42, with a sensitivity of 85% (95% CI, 75%–94%) and specificity of 63% (95% CI, 54%–71%). The IVH score was the most effective grading system for predicting acute hydrocephalus, with a ROC AUC of 0.85 (95% CI, 0.79–0.89). In multivariate analysis, the Hijdra scale was the only independent predictor of the occurrence of DCI (hazard ratio, 1.18; 95% CI, 1.10–1.27). Conclusions: Although these results have yet to be prospectively confirmed, our findings suggest that the Hijdra scale may be a good predictor of DCI and could be useful in daily clinical practice.

WM1-2 SFX-01 after subarachnoid haemorrhage: protocol of a multi-centre, phase II, double-blinded, randomised controlled trial

2019 ◽  
Vol 90 (3) ◽  
pp. e1.1-e1
Author(s):  
A Zolnourian ◽  
P Holton ◽  
I Galea ◽  
D Bulters
Keyword(s):  
Clinical Trial ◽  
Statistical Analysis ◽  
Subarachnoid Haemorrhage ◽  
Phase Ii ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Daily Basis ◽  
Safety And Efficacy ◽  
Randomised Controlled ◽  
Double Blinded

ObjectivesTo assess the safety and efficacy of SFX-01 after subarachnoid haemorrhage.DesignSFX-01 is a synthetic agent that contains sulforaphane that has been shown to be neuroprotective in animal models of subarachnoid haemorrhage. This is a phase II double-bilinded, placebo-controlled randomised clinical trial.SubjectsTarget of 90 patients with fisher 3 or 4 subarachnoid haemorrhage.MethodsPatients admitted to the three recruiting centres within 48 hours of ictus will be randomly allocated to placebo or SFX-01. The randomisation is stratified into WFNS 1–3 or 4–5. Participants will receive the trial medication in a capsule format twice-daily for 28 days. Patients will have transcranial dopplers (TCD) on alternate daily basis for at least 7 days. The maximum mean MCA flow velocity as well as safety are the two primary end-points. All patients will have paired blood and CSF taken at day 7 either through an LP or via EVD sampling. Follow-ups are performed at day 28, 3 months and 6 months which include safety bloods, functional questionnaires, mRS, GOSE and MRI.Results64 (71% of the target) patients have been enrolled. 35 patients have completed the study. Statistical analysis of the TCD data will be performed at the end of the trial. The mortality is at 9.5% (6). DSMB have met twice since the start of the trial and there have been no safety concerns.ConclusionsThe trial is recruiting on the planned trajectory and at this rate we are projected to complete the trial by the end of the year.

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