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.

scholarly journals Safety and efficacy of different administration order on paradoxical reactions following midazolam in children: a randomised, controlled trial

2019 ◽  
Author(s):  
change zhu ◽  
Saiji Zhang ◽  
Rong Wei
Keyword(s):  
Controlled Trial ◽  
Anesthesia Induction ◽  
Blank Group ◽  
Study Objective ◽  
Safety And Efficacy ◽  
Self Injury ◽  
Increase Risk ◽  
Randomised Controlled ◽  
Double Blinded ◽  
Fentanyl Group

Abstract Study Objective Midazolam is commonly used for Anesthesia induction. However, the paradoxical reactions increase risk of self-injury and bring pressure on anesthesiologist. Although various drugs have been showed effective, but the potential adverse effects limit the application. We compared safety and efficacy of different administration order on the occurrence of paradoxical reactions in children.Design Prospective, randomized, double-blinded study.Setting Operating room of a university-affiliated hospital.Patients 1306 ASA physical status I pediatric patients, aged 6 months to 12 years, scheduled for general anesthesia.Interventions Patients were divided into three groups. In the fentanyl group, patients were given fentanyl followed by midazolam at induction; In the midazolam group patients received midazolam followed by fentanyl at induction; In the blank group, patients were given saline followed by fentanyl at induction. Propofol was administrated 2.5 mg/kg intravenously (IV).Measurements Onset of paradoxical reactions and BIS values were observed and recorded.Main Results Preferentially and slowly injecting fentanyl could decrease the incidence of paradoxical reaction (p<0.05). Children displaying paradoxical reactions were mostly aged 8 months-2 years old (p = 0.001). Bispectralindex values increased significantly when paradoxical reactions burst out (p< 0.05). There were no significant differences in terms of side-effects.Conclusion Changing the administration order was safe and effective to decrease the incidence of paradoxical reactions.

scholarly journals A double blind, randomised, placebo-controlled trial to evaluate the efficacy of metformin to treat preterm pre-eclampsia (PI2 Trial): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e025809 ◽  
Author(s):  
Catherine Cluver ◽  
Susan P Walker ◽  
Ben W Mol ◽  
David Hall ◽  
Richard Hiscock ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Biological Effects ◽  
Controlled Trial ◽  
Disease Process ◽  
Major Complication ◽  
Definitive Treatment ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Randomised Controlled

IntroductionPre-eclampsia is a major complication of pregnancy, globally responsible for 60 000 maternal deaths per year, and far more fetal losses. There is no definitive treatment other than delivery. A therapeutic that could quench the disease process would be useful to treat preterm pre-eclampsia, as it could allow these pregnancies to safely continue to a gestation where fetal outcomes are significantly improved. We have published preclinical data to show that metformin, a drug known to be safe in pregnancy and commonly used to treat gestational diabetes, has potent biological effects making it another promising candidate to treat pre-eclampsia. Here, we describe a phase II clinical trial to examine whether administering extended-release metformin may be effective in treating women with preterm pre-eclampsia (PI2 Trial).MethodsThe PI2 Trial is a phase II, double blind, randomised controlled trial that aims to recruit 150 women with preterm pre-eclampsia (gestational age 26+0 to 31+6 weeks) who are being managed expectantly. Participants will be randomised to receive either 3 g of metformin or placebo daily. The primary outcome is time from randomisation until delivery. A delay in delivery of 5 days is assumed to be clinically relevant. The secondary outcomes will be a maternal composite and neonatal composite outcome. All other outcomes will be exploratory. We will record adverse events.Ethics and disseminationThis study has ethical approval (Protocol number M16/09/037 Federal Wide Assurance Number 00001372, Institutional Review Board Number IRB0005239), is registered with the Pan African Clinical Trial Registry (PACTR201608001752102) and the South African Medicine Control Council (20170322). Data will be presented at international conferences and published in peer-reviewed journals.Trial registration numberPACTR201608001752102; Pre-results.

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