Previous Studies

ALIAS - High-Dose Albumin Therapy for Neuroprotection In Acute Ischemic Stroke

The purpose of the ALIAS trial was to evaluate the effectiveness of high-dose, intravenous human serum albumin.  In animal laboratory studies it has been shown that it reduces the size of the infarction (amount of tissue death) in the brain and improves neurological function after a stroke and also decreases or eliminates the brain swelling that may occur; these effects may reduce or prevent the brain damage resulting from a stroke in humans.

ALIAS aimed to assess whether albumin given within five hours of the onset of acute ischemic stroke increased the proportion of patients with a favorable outcome. The findings showed no clinical benefit of 25% albumin in patients with ischemic stroke; however, they should not discourage further efforts to identify effective strategies to protect the ischemic brain, especially because of preclinical literature showing convincing proof-of-principle for the possibility of this outcome. For more detailed information about the the trial and findings click: https://siren.network/clinical-trials/alias

ATACH-II: Antihypertensive Treatment of Acute Cerebral Hemorrhage

The report from a National Institute of Neurological Disorders and Stroke Workshop on priorities for clinical research in intracerebral hemorrhage (ICH) in December 2003 recommended clinical trials for evaluation of blood pressure (BP) management in acute ICH as a leading priority. The Special Writing Group of the Stroke Council of the American Heart Association in 1999 and 2007 emphasized the need for clinical trials to ensure evidence-based treatment of acute hypertension in ICH. Consequently, we propose to conduct a five-year international, multicenter, open-labeled, randomized, controlled, Phase III trial to determine the efficacy of early, intensive antihypertensive treatment using intravenous nicardipine for acute hypertension in subjects with co-morbid hypertension and spontaneous supratentorial ICH. The primary hypothesis of this large, streamlined, focused trial is that the group treated with intensive BP reduction (systolic BP [SBP] of 140 mmHg or less - hereafter referred to as the intensive treatment) using intravenous nicardipine infusion for 24 hours reduces the proportion of death and disability at 3 months by 10% or greater compared with the group treated with the standard BP reduction (SBP of 180 mmHg or less - hereafter referred to as the standard treatment) among patients with ICH treated within 4.5 hours of symptom onset. The underlying mechanism for this expected beneficial effect of intensive treatment is mediated through reduction of the rate and magnitude of hematoma expansion observed in approximately 38% of patients with acute ICH. The trial will recruit a maximum of 1,280 subjects with ICH who meet the eligibility criteria. The primary outcome is the proportion of death and disability at 3 months defined by modified Rankin scale (mRS) score of 4 to 6. The proposed clinical trial is the natural extension of numerous case series, a subsequent pilot trial funded by the National Institutes of Health National Institute of Health (NIH), and a preliminary randomized controlled trial in this patient group funded by the Australian National Health and Medical Research Council, that have recently confirmed the safety and tolerability of both the regimen and goals of the antihypertensive treatment in acutely hypertensive patients with ICH proposed in the present trial. The proposed trial will have important public health implications by providing necessary information regarding the efficacy and safety of antihypertensive treatment of acute hypertension observed in up to 75% of the subjects with ICH. BP treatment represents a strategy that can be made widely available without the need of specialized equipment and personnel and therefore can make a major impact upon outcome in patients with ICH. Substantial reduction in morbidity and mortality appears possible if the estimates of treatment effect sizes from current pilot trials are accurate.  For more detailed information about the the trial and findings click: https://classic.clinicaltrials.gov/ct2/show/NCT01176565

RAMPART - Rapid Anticonvulsant Medication Prior to Arrival Trial 

Seizures are a common medical prob­lem. Most seizures are brief and stop by themselves, but those that don’t stop in seconds or minutes are a dangerous life-threatening medical emergency. Paramedics often have medications that can stop the seizures, but the best way to give them is not known.

The Rapid Anticonvulsant Medications Prior to Arrival Trial (RAMPART) was a research study to figure out whether giving anti-seizure medicine worked better and more quickly when given through an IV or when given as a shot in the muscle. Two similar medicines - midazolam and lorazepam - were used. Both were already used by paramedics in the field and by doctors in the hospital to stop seizures. Lorazepam is commonly given IV, and midazolam is commonly given as a shot in the muscle. For more detailed information about the the trial and findings click: https://siren.network/clinical-trials/rampart#About%20Study

ProTECT - Progesterone for the Treatment of Traumatic Brain Injury (Experimental Clinical Treatment Trial) 

Moderate to severe traumatic brain injury (TBI) is a common medical problem which can cause brain damage or even death. Scientists have not been able to come up with an effective drug treatment for TBI, despite trying for over 30 years. ProTECT™ III, more commonly referred to as the Protective Effects of Progesterone, was a research study to see if progesterone, a hormone normally found in our bodies, was able to limit the amount of brain damage from TBI.  Many previous animal studies and two small studies in humans suggested that progesterone, given after TBI, may result in less brain damage.  The ProTECT III study tested these findings and determined if this treatment could be helpful in adults with moderate to severe TBI. For more detailed information about the the trial and findings click: https://siren.network/clinical-trials/protect

POINT - Platelet-Oriented Inhibition in New TIA and Minor Ischaemic Stroke Trial 

POINT is a randomized, double-blind, multicenter clinical trial to determine whether clopidogrel 75mg/day (after a loading dose of 600mg) is effective in improving survival free from major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours time last known free of new ischemic symptoms of TIA or minor ischemic stroke in subjects receiving aspirin 50-325mg/day. For more detailed information about the the trial and findings click: https://siren.network/clinical-trials/point

SHINE - Stroke Hyperglycemia Insulin Network Effort 

This was a multicenter, prospective, randomized, controlled trial, with blinded outcomes. It aimed to determine the efficacy and provide further safety data on the use of insulin infusion therapy for glucose control in hyperglycemic acute ischemic stroke patients. Treatment with insulin infusion was given within 12 hours of symptom onset. The primary outcome assessed at 90 days was the difference in favorable outcome measured by the modified Rankin Scale score in the insulin infusion group compared to the control group. The rates of symptomatic hypoglycemia with prolonged neurological worsening as well as asymptomatic hypoglycemia was assessed. The secondary outcomes assessed additional neurological and functional outcomes. This highly collaborative research program is nearly guaranteed to advance the field of stroke care. For more detailed information about the the trial and findings click: https://siren.network/clinical-trials/shine

ESETT - The Established Status Epilepticus Treatment Trial 

he Established Status Epilepticus Treatment Trial (ESETT) is a multicenter, randomized, double-blind, comparative effectiveness study of fos-phenytoin, levetiracetam, and valproic acid in subjects with benzodiazepine-refractory status epilepticus. Patients will be recruited by two national emergency research networks:  Neurology Emergency Treatment Trials (NETT) network and Pediatric Emergency Care and Applied Research Network (PECARN).  Each network has successfully undertaken a Status Epilepticus treatment trial under exception from informed consent (EFIC) rules. For more detailed information about the the trial and findings click: https://siren.network/clinical-trials/esett