Study: NCT00178711

Adverse event: Elevated Intracranial Pressure
Serious: yes
Organ System: Nervous system disorders
Notes: Intracranial pressure levels greater than 30mmHg for more than 30 minutes or levels greater than 40 mmHg for 5 minutes, non-responsive to maximal medical management and requires initiation of barbiturate coma.
Frequency: 14 affected / 52 at risk

Adverse event: Decreased Cerebral Perfusion Pressure
Serious: yes
Organ System: Nervous system disorders
Notes: Cerebral perfusion pressure \<50 mmHg for each occurrence documented on the physiology case report form during hourly data collection
Frequency: 21 affected / 52 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: New hemorrhage into subdural space requiring surgery
Frequency: 1 affected / 52 at risk

Adverse event: Intraparenchymal Hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: New hemorrhage into brain tissue requiring surgery
Frequency: 1 affected / 52 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: acute hypoxia associated with high probability ventilation-perfusion scan, positive Spiral CT scan, computed tomography angiography or MRI associated with hypotension or persistent SaO2 less than 90% for greater than or equal to 2 hours
Frequency: 2 affected / 52 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Presence of all 3 of the following;

1. bilateral pulmonary infiltrates
2. a PCWP\<18 mm Hg
3. a consistent PO2:FiO2 ratio of \<200 for greater than or equal to 3 hours
Frequency: 2 affected / 52 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Notes: rectal or core temperature less than or equal to 32 degrees C for any period of time not induced or related to general anesthesia
Frequency: 1 affected / 52 at risk

Adverse event: Multiple Organ Dysfunction
Serious: yes
Organ System: General disorders
Notes: a pattern of simultaneous or near simultaneous organ failure in at least 3 organ systems.
Frequency: 1 affected / 52 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: pO2 \<50 mm Hg on greater than or equal to 70% FIO2 or persistent O2 saturation \<94% for greater than or equal to 2 hours
Frequency: 1 affected / 52 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: systolic blood pressure \< 90 mm Hg or Mean Arterial Pressure \< 70 mm Hg for 2 or more consecutive hours associated with end-organ failure due to hypo-perfusion
Frequency: 1 affected / 52 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: sudden or unexpected cessation of pumping action of the heart
Frequency: 1 affected / 52 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: presence of blood in the pleural cavity which is not present on admission chest x-ray which drains \>200 ml/hr for greater than or equal to 2 hours
Frequency: 1 affected / 52 at risk

Adverse event: Elevated Intracranial Pressure
Serious: no
Organ System: Nervous system disorders
Notes: Intracranial pressure \> 20 mm Hg for 2 or more consecutive hours but that does not meet the definition of critical elevated intracranial pressure (See serious adverse events for that definition)
Frequency: 23 affected / 52 at risk

Adverse event: Decreased Cerebral Perfusion Pressure
Serious: no
Organ System: Nervous system disorders
Notes: Cerebral perfusion pressure \<60 mm Hg for 2 or more consecutive hours but that does not meet the definition of critical decreased perfusion pressure (See serious adverse events for that definition)
Frequency: 3 affected / 52 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: new or progressive infiltrated, consolidation or pleural effusion on chest x-ray and at least one of the following:

1. New onset of purulent sputum
2. isolation of a etiologic agent
3. Diagnostic antibody titer or detection of viral antigen
Frequency: 28 affected / 52 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Fever \>38C and positive urine culture or physician diagnosis of urinary tract infection
Frequency: 3 affected / 52 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: diagnostic (ultrasound, venogram, Doppler studies) evidence of deep vein thrombosis
Frequency: 6 affected / 52 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: presence of air in the pleural cavity which is not present on admission x-ray and is not associated with hypoxemia or respiratory distress
Frequency: 4 affected / 52 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: new ulceration of the skin and subcutaneous tissue which is pressure-related; code only Stage II ulcers or higher (through epidermis and dermis)
Frequency: 4 affected / 52 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: Systolic blood pressure \<90 mm Hg or Mean arterial pressure \<70 mm Hg for 2 or more consecutive hours but not associated with end-organ failure due to hypoperfusion (see Serious Adverse events for definition of critical hypotension)
Frequency: 7 affected / 52 at risk

Adverse event: Elevated Intracranial Pressure
Serious: yes
Organ System: Nervous system disorders
Notes: Intracranial pressure levels greater than 30mmHg for more than 30 minutes or levels greater than 40 mmHg for 5 minutes, non-responsive to maximal medical management and requires initiation of barbiturate coma.
Frequency: 9 affected / 45 at risk

Adverse event: Decreased Cerebral Perfusion Pressure
Serious: yes
Organ System: Nervous system disorders
Notes: Cerebral perfusion pressure \<50 mmHg for each occurrence documented on the physiology case report form during hourly data collection
Frequency: 13 affected / 45 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: New hemorrhage into subdural space requiring surgery
Frequency: 1 affected / 45 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Presence of all 3 of the following;

1. bilateral pulmonary infiltrates
2. a PCWP\<18 mm Hg
3. a consistent PO2:FiO2 ratio of \<200 for greater than or equal to 3 hours
Frequency: 2 affected / 45 at risk

Adverse event: Multiple Organ Dysfunction
Serious: yes
Organ System: General disorders
Notes: a pattern of simultaneous or near simultaneous organ failure in at least 3 organ systems.
Frequency: 1 affected / 45 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: sudden or unexpected cessation of pumping action of the heart
Frequency: 1 affected / 45 at risk

Adverse event: Tentorial Herniation
Serious: yes
Organ System: Nervous system disorders
Notes: acute clinical neurologic deterioration with pupillary dilation
Frequency: 1 affected / 45 at risk

Adverse event: Blood Stream Infection
Serious: yes
Organ System: Infections and infestations
Notes: Has a recognized pathogen from 1 or more blood cultures and organism is not related to infection at another site; or has fever \>38C or chills or hypotension and positive blood culture
Frequency: 2 affected / 45 at risk

Adverse event: Catheter Positive Culture
Serious: yes
Organ System: Infections and infestations
Notes: \>15 colonies of pathogenic microorganisms cultured from an arterial or central venous catheter tip associated with clinical sepsis or laboratory-confirmed bloodstream infection
Frequency: 1 affected / 45 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Presence of air in the pleural cavity which is not present on admission x-ray associated with hypoxemia or respiratory distress
Frequency: 1 affected / 45 at risk

Adverse event: Elevated Intracranial Pressure
Serious: no
Organ System: Nervous system disorders
Notes: Intracranial pressure \> 20 mm Hg for 2 or more consecutive hours but that does not meet the definition of critical elevated intracranial pressure (See serious adverse events for that definition)
Frequency: 18 affected / 45 at risk

Adverse event: Decreased Cerebral Perfusion Pressure
Serious: no
Organ System: Nervous system disorders
Notes: Cerebral perfusion pressure \<60 mm Hg for 2 or more consecutive hours but that does not meet the definition of critical decreased perfusion pressure (See serious adverse events for that definition)
Frequency: 3 affected / 45 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: new or progressive infiltrated, consolidation or pleural effusion on chest x-ray and at least one of the following:

1. New onset of purulent sputum
2. isolation of a etiologic agent
3. Diagnostic antibody titer or detection of viral antigen
Frequency: 28 affected / 45 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Fever \>38C and positive urine culture or physician diagnosis of urinary tract infection
Frequency: 6 affected / 45 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: diagnostic (ultrasound, venogram, Doppler studies) evidence of deep vein thrombosis
Frequency: 6 affected / 45 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: presence of air in the pleural cavity which is not present on admission x-ray and is not associated with hypoxemia or respiratory distress
Frequency: 4 affected / 45 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: new ulceration of the skin and subcutaneous tissue which is pressure-related; code only Stage II ulcers or higher (through epidermis and dermis)
Frequency: 2 affected / 45 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: Systolic blood pressure \<90 mm Hg or Mean arterial pressure \<70 mm Hg for 2 or more consecutive hours but not associated with end-organ failure due to hypoperfusion (see Serious Adverse events for definition of critical hypotension)
Frequency: 3 affected / 45 at risk

Adverse event: Elevated Intracranial Pressure
Serious: yes
Organ System: Nervous system disorders
Notes: Intracranial pressure levels greater than 30mmHg for more than 30 minutes or levels greater than 40 mmHg for 5 minutes, non-responsive to maximal medical management and requires initiation of barbiturate coma.
Frequency: 4 affected / 67 at risk

Adverse event: Decreased Cerebral Perfusion Pressure
Serious: yes
Organ System: Nervous system disorders
Notes: Cerebral perfusion pressure \<50 mmHg for each occurrence documented on the physiology case report form during hourly data collection
Frequency: 4 affected / 67 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Presence of all 3 of the following;

1. bilateral pulmonary infiltrates
2. a PCWP\<18 mm Hg
3. a consistent PO2:FiO2 ratio of \<200 for greater than or equal to 3 hours
Frequency: 1 affected / 67 at risk

Adverse event: Multiple Organ Dysfunction
Serious: yes
Organ System: General disorders
Notes: a pattern of simultaneous or near simultaneous organ failure in at least 3 organ systems.
Frequency: 1 affected / 67 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: systolic blood pressure \< 90 mm Hg or Mean Arterial Pressure \< 70 mm Hg for 2 or more consecutive hours associated with end-organ failure due to hypo-perfusion
Frequency: 1 affected / 67 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: sudden or unexpected cessation of pumping action of the heart
Frequency: 1 affected / 67 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: presence of blood in the pleural cavity which is not present on admission chest x-ray which drains \>200 ml/hr for greater than or equal to 2 hours
Frequency: 1 affected / 67 at risk

Adverse event: Blood Stream Infection
Serious: yes
Organ System: Infections and infestations
Notes: Has a recognized pathogen from 1 or more blood cultures and organism is not related to infection at another site; or has fever \>38C or chills or hypotension and positive blood culture
Frequency: 3 affected / 67 at risk

Adverse event: Clinical Sepsis
Serious: yes
Organ System: General disorders
Notes: At least one of following:

fever \> 38 degrees C SBP \< 90 mmHg oliguria (\< 20 cc/hr) AND blood culture NOT done or NO organisms in blood no apparent infection at another site physician institutes treatment for sepsis
Frequency: 1 affected / 67 at risk

Adverse event: Elevated Intracranial Pressure
Serious: no
Organ System: Nervous system disorders
Notes: Intracranial pressure \> 20 mm Hg for 2 or more consecutive hours but that does not meet the definition of critical elevated intracranial pressure (See serious adverse events for that definition)
Frequency: 8 affected / 67 at risk

Adverse event: Decreased Cerebral Perfusion Pressure
Serious: no
Organ System: Nervous system disorders
Notes: Cerebral perfusion pressure \<60 mm Hg for 2 or more consecutive hours but that does not meet the definition of critical decreased perfusion pressure (See serious adverse events for that definition)
Frequency: 5 affected / 67 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: new or progressive infiltrated, consolidation or pleural effusion on chest x-ray and at least one of the following:

1. New onset of purulent sputum
2. isolation of a etiologic agent
3. Diagnostic antibody titer or detection of viral antigen
Frequency: 17 affected / 67 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Fever \>38C and positive urine culture or physician diagnosis of urinary tract infection
Frequency: 5 affected / 67 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: new ulceration of the skin and subcutaneous tissue which is pressure-related; code only Stage II ulcers or higher (through epidermis and dermis)
Frequency: 4 affected / 67 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: Systolic blood pressure \<90 mm Hg or Mean arterial pressure \<70 mm Hg for 2 or more consecutive hours but not associated with end-organ failure due to hypoperfusion (see Serious Adverse events for definition of critical hypotension)
Frequency: 6 affected / 67 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: pO2 \<50 mm Hg on greater than or equal to 70% FIO2 or persistent O2 saturation \<94% for greater than or equal to 2 hours
Frequency: 1 affected / 68 at risk

Adverse event: Tentorial Herniation
Serious: yes
Organ System: Nervous system disorders
Notes: acute clinical neurologic deterioration with pupillary dilation
Frequency: 1 affected / 68 at risk

Adverse event: Blood Stream Infection
Serious: yes
Organ System: Infections and infestations
Notes: Has a recognized pathogen from 1 or more blood cultures and organism is not related to infection at another site; or has fever \>38C or chills or hypotension and positive blood culture
Frequency: 3 affected / 68 at risk

Adverse event: Epidural haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: New hemorrhage into epidural space. (Does not include EDH from initial injury but includes a re-bleed into the previously evacuated surgical site
Frequency: 1 affected / 68 at risk

Adverse event: Elevated Intracranial Pressure
Serious: no
Organ System: Nervous system disorders
Notes: Intracranial pressure \> 20 mm Hg for 2 or more consecutive hours but that does not meet the definition of critical elevated intracranial pressure (See serious adverse events for that definition)
Frequency: 7 affected / 68 at risk

Adverse event: Decreased Cerebral Perfusion Pressure
Serious: no
Organ System: Nervous system disorders
Notes: Cerebral perfusion pressure \<60 mm Hg for 2 or more consecutive hours but that does not meet the definition of critical decreased perfusion pressure (See serious adverse events for that definition)
Frequency: 1 affected / 68 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: new or progressive infiltrated, consolidation or pleural effusion on chest x-ray and at least one of the following:

1. New onset of purulent sputum
2. isolation of a etiologic agent
3. Diagnostic antibody titer or detection of viral antigen
Frequency: 17 affected / 68 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Fever \>38C and positive urine culture or physician diagnosis of urinary tract infection
Frequency: 4 affected / 68 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: diagnostic (ultrasound, venogram, Doppler studies) evidence of deep vein thrombosis
Frequency: 2 affected / 68 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: presence of air in the pleural cavity which is not present on admission x-ray and is not associated with hypoxemia or respiratory distress
Frequency: 2 affected / 68 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: new ulceration of the skin and subcutaneous tissue which is pressure-related; code only Stage II ulcers or higher (through epidermis and dermis)
Frequency: 2 affected / 68 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: Systolic blood pressure \<90 mm Hg or Mean arterial pressure \<70 mm Hg for 2 or more consecutive hours but not associated with end-organ failure due to hypoperfusion (see Serious Adverse events for definition of critical hypotension)
Frequency: 4 affected / 68 at risk