New England SIREN Group

Overview

The New England Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Group is a nation-wide, collaborative effort that conducts high-quality, multi-site clinical trials to improve the outcomes for patients with a range of emergency conditions.

The New England Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Group is a nation-wide, collaborative effort that conducts high-quality, multi-site clinical trials to improve the outcomes for patients with a range of emergency conditions. In collaboration with partners across New England, we will both lead and participate in large scale definitive phase III trials for conditions such as traumatic brain injury, cardiac arrest, and others. Upcoming SIREN research studies aim to improve care for patients with traumatic brain injuries and cardiac arrests. The SIREN network will lead the next generation of definitive emergency care trials.

New England SIREN Members

• Massachusetts General Hospital
• Beth Israel Deaconess Medical Center
• Boston Children’s Hospital
• Boston Medical Center
• Brigham and Women's Hospital
• UMass Memorial Health Care
• Yale-New Haven Hospital
• Visit the SIREN National website

Recently Completed Studies

ESETT - The Established Status Epilepticus Treatment Trial

ESETT aimed to determine which of 3 FDA approved medications is the best for treating emergency seizures that do not stop, a condition known as status epilepticus. Patients were given either fos-phenytoin (also known as Cerebyx, or Prodilantin), valproic acid (also known as Depakote), or levetiracetam (also known as Keppra). The ESETT primary study results were published in the New England Journal of Medicine. The study found that these three medications appear to be equally safe and effective. You can also read the NIH press release about the ESETT trial.

If you have any questions, please contact us at SIREN@partners.org.

You can also visit the ESETT national study website for more information.

Current Studies

BOOST-3 – Brain Oxygen Optimization in Severe TBI Phase 3 Trial

BOOST-3 is aiming to determine whether a treatment protocol based on brain tissue oxygen monitoring improves neurologic outcome in this most severely injured group of patients as compared to the standard care of intracranial pressure monitoring only. BOOST-3 will use a special set of rules called Exception from Informed Consent (EFIC) for emergency research. The trial plans to enroll a maximum of 1094 subjects.

If you would like to "opt out" or make sure your child is not enrolled in this trial, please contact us at SIREN@partners.org.

The article based on the BOOST phase 2 trial is called "Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial."

You can also visit the BOOST-3 national study website for more information.

ICECAP – Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients

ICECAP is aiming to characterize the duration response curve for cooling/hypothermia and identify an optimal duration of cooling that can improve outcomes in comatose patients with out of hospital cardiac arrest. The trial plans to enroll a maximum of 1800 subjects.

You can also visit ICECAP national study website for more information.

HOBIT – Hyperbaric Oxygen Brain Injury Treatment Trial

There continues to be an overarching problem of high mortality and poor outcome for victims of severe traumatic brain injury (TBI). Preclinical and clinical investigations indicate that hyperbaric oxygen (HBO2) has a positive impact on reducing brain injury and improving outcomes in severe TBI. By markedly increasing oxygen (O2) delivery to the traumatized brain, HBO2 can reverse the lack of O2 that precipitates cellular energy failure and subsequent brain cell death.

HOBIT is aiming to determine the most effective combination of HBO2 treatment parameters (e.g., pressure, frequency, etc.) and HBO2 dose schedule without producing O2 toxicity and clinical complications that are most likely to demonstrate improvement in the outcome of TBI patients. This trial will provide important data and information to plan a definitive phase III efficacy trial. The HOBIT trial plans to enroll a maximum of 200 subjects.

You can also visit the HOBIT national study website for more information.

Upcoming Studies

KETOSIS – Ketogenic Emergency Treatment Of Status Epilepticus In SIREN

There is a critical need for prospective, randomized trials establishing safe and effective treatments for refractory status epilepticus (RSE). Ketogenic diets (high fat, low carbohydrate enteral formulas designed to induce ketone body production or ketonemia) are effective in the treatment of drug-resistant epilepsy.

KETOSIS proposes to determine if the most effective ketogenic enteral formula ratio needed to induce ketonemia within 24 hours of initiation in the setting of established refractory status epilepticus as an adjunct to standard medical care, while avoiding intervention-limiting metabolic acidosis. The primary endpoint is presence or absence of ketonemia (≥ 1 mmol/L blood ß-hydroxybutyrate) within 24 hours of formula initiation without a Grade 4 intervention-limiting metabolic acidosis by 48 hours (pH < 7.3, persistent over a 6 or more consecutive hours). There are several safety, secondary efficacy, and exploratory endpoints. The KETOSIS trial plans to enroll 210 subjects.

You can also visit the KETOSIS national study website for more information.