Study: NCT00299416

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Notes: Three patients died (SAE unrelated to study interventions):

(1) symptomatic hemorrhage due to severity of stroke

(1) malignant edema/ herniation

(1) unrelated medical condition (withdrawal of care requested by family)
Frequency: 3 affected / 30 at risk

Adverse event: Neuroworsening
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Cholecysitits
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Reduced respiratory drive
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Parenchymal hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: 3 symptomatic

1 asymptomatic
Frequency: 4 affected / 30 at risk

Adverse event: Thrombotic thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Attributed to clopidrogrel and required treatment with plasmapheresis
Frequency: 1 affected / 30 at risk

Adverse event: Sedation
Serious: no
Organ System: Surgical and medical procedures
Notes: Sedation noted:

* (2)Demerol dose was reduced/held. Sedation resolved.
* (2)Acidosis secondary to sedation. Treated/ resolved.
Frequency: 4 affected / 30 at risk

Adverse event: Elevated CK
Serious: no
Organ System: Cardiac disorders
Notes: Elevated Ck noted -asymptomatic/ resolved
Frequency: 10 affected / 30 at risk

Adverse event: Elevated Amylase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Elevated amylase noted:Asymptomatic/resolved.
Frequency: 2 affected / 30 at risk

Adverse event: Device failure
Serious: no
Organ System: Surgical and medical procedures
Notes: Cooling machine failure (3) Icy catheter tubing leak (1)
Frequency: 4 affected / 30 at risk

Adverse event: Asymptomatic hemorrhagic transformation
Serious: no
Organ System: Nervous system disorders
Notes: Noted/ resolved
Frequency: 7 affected / 30 at risk

Adverse event: Elevated WBC
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: No fever/ symptoms; resolved without treatment.
Frequency: 2 affected / 30 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (1)Treated with lasix and nebulizer treatment. Resolved.

(1)Shortness of breath, oxygen saturation 87%, infiltrates on CXR. Treated with BiPAP \& lasix
Frequency: 2 affected / 30 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: * (2)UTI treated/ resolved.
* GNR central line infection. Line removed/ antibiotic added. Resolved.
* MRSA pneumonia treated.
* Possible pneumonia treated with naficillin/ ceftin.
* Pneumonia treated with antibiotics. Resolved.
Frequency: 6 affected / 30 at risk

Adverse event: Low Hgb/ Hct
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Abnormal Labs (chem.)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (1)Low K+ - replaced/ resolved

(1)Elevated K+ - treated

(1)Elevated Mg - asymptomatic/ resolved
Frequency: 3 affected / 30 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: (1) A. fib

(1)A. fib with AV block
Frequency: 3 affected / 30 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk