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Table 4 Serious adverse events (SAE)

From: Study of therapeutic hypothermia (32 to 35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial): outcome of the pilot phase of the trial

1. Hospitalization

Bleeding - defined as a new haemorrhage requiring 2 units of packed red cells

Unrelated

2. Hospitalization

Bleeding - defined as a new hemorrhage requiring 2 units of packed red cells

Unrelated

3. Life threatening

Cerebral perfusion pressure <50 mmHg for 15 minutes

Unrelated

4. Death

Cardiovascular instability - systolic blood pressure <90 mmHg for 30 minutes

Unrelated

5. Life threatening and persistent of significant disability or incapacity

Cerebral perfusion pressure <50 mmHg for 15 minutes

Unrelated

6. Death

Cerebral perfusion pressure <50 mmHg for 15 minutes

Unrelated

7. Life threatening

Cerebral perfusion pressure <50 mmHg for 15 minutes

Unrelated

  1. Each line describes an SAE reported during the pilot phase of the Eurotherm3235Trial, and each SAE is classified according to International Conference on Harmonisation, Good Clinical Practice (http://www.ich.org/).