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Table 1 Eligibility criteria

From: Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol

Eligibility criteria


1. 18–80 years of age

The target study population is adults, hence ≥ 18 years. Individuals > 80 years have a lower likelihood of successfully tolerating aggressive treatment for PASE, including escalating doses of intravenous anesthetic infusions, and are subjected to high rates of withdrawal of life sustaining therapy in the early post-cardiac arrest period. The upper age limit of 80 years has been used in other cardiac arrest trials

2. Non-traumatic cardiac arrest of any rhythm, etiology and location of occurrence

PASE may occur following cardiac arrest of any type, regardless of the location of its occurrence (out-of hospital vs in-hospital) or the type of non-perfusing rhythm. Traumatic cardiac arrests have different organ injury and clinical trajectories than non-traumatic cardiac arrests

3. Requiring anesthetic infusion for any indication

To standardize starting point of anesthetic infusions prior to initiation of therapeutic algorithm for PASE

4. Arterial access for frequent blood sampling

Facilitate timely and standardized collection of blood sampling for pharmacokinetic analyses

5. Established enteral access within 48 h of PASE onset

There is currently no parenteral form of vigabatrin, thus, enteral access is a prerequisite for participation


1. Prior history of generalized epilepsy

Vigabatrin may exacerbate certain types of primary epilepsy such as primary generalized epilepsy

2. Gastrointestinal surgery within the last 21 days

Avoid confounding effect that could affect absorption of study drug

3. Pregnancy

There is currently no controlled data verifying the safety of vigabatrin dosing in pregnant women, so they are excluded from this study

4. PASE onset preceding initiation of EEG monitoring

If PASE onset occurred prior to the initiation of monitoring, the start time for the onset of PASE cannot be determined