Trial Outcomes & Findings for Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury (NCT NCT00178711)

Last Updated: 2014-09-17

Results Overview

The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

232 participants

Primary outcome timeframe

6 months with a window of plus or minus one month

Results posted on

2014-09-17

Participant Flow

Patients were enrolled in hospitals of University of Texas Health Science Center at Houston, University of Calgary, University of Pittsburgh, St. Louis University, Charleston Area Medical Center, and University of New Mexico.Enrollment occurred from December 2005 to June 2009 with follow-up from June 2006 through December 2009

Enrollment criteria at the first eligibility assessment were ages 16-45, non-penetrating brain injury, and not responsive to instructions. 232 participants met these criteria and also had none of a first set of exclusion criteria. At the second eligibility assessment, 97 patients had none of a second set of exclusion criteria.

Participant milestones

Participant milestones
Measure	Hypothermia There were two sets of exclusion criteria-one in the field; the other after resuscitation in the ER. In the field, patients were excluded for suspected pregnancy, systolic blood pressure \<110 mm Hg, diastolic blood pressure \<60 mm Hg, sustained heart rate \>120 beats per minute, or failure to be reached by study-affiliated personnel within 2.5 hours of injury. Those that did not have any of the first set of exclusion criteria were further assessed for the presence of Glasgow Coma Scale 3-8 without life-threatening associated injuries. The second set of exclusion criteria were GCS 3 with nonreactive pupils, GCS 7-8 with normal brain CT scan, inability to obtain an accurate GCS, Abbreviated Injury Severity Score \>4 for organs other than brain4, systolic blood pressure \<110 mm Hg or diastolic blood pressure \<60 mm Hg, persistent hypoxia, (oxygen saturation \< 94%), or positive pregnancy test.	Control 45 patients who had none of the second set of exclusion criteria and who has been randomized to normothermia served as the control group
Overall Study STARTED	52	45
Overall Study COMPLETED	52	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypothermia n=52 Participants Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours. Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours	Control n=45 Participants Treated at normothermia	Total n=97 Participants Total of all reporting groups
Age, Continuous	26 years STANDARD_DEVIATION 9 • n=5 Participants	31 years STANDARD_DEVIATION 11 • n=7 Participants	28 years STANDARD_DEVIATION 10 • n=5 Participants
Age, Categorical <=18 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	38 Participants n=7 Participants	83 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months with a window of plus or minus one month

Population: Intention to Treat

Outcome measures

Outcome measures
Measure	Hypothermia n=52 Participants Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours. Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours	Control n=45 Participants treated at normothermia
The Dichotomized Glasgow Outcome Scale	31 participants with a poor outcome Interval 0.76 to 1.53	25 participants with a poor outcome Interval 0.76 to 1.53

Adverse Events

Randomized to Hypothermia and Hypothermia Maintained

Serious events: 30 serious events

Other events: 42 other events

Deaths: 0 deaths

Randomized to Normothermia and Normothermia Maintained

Serious events: 20 serious events

Other events: 38 other events

Deaths: 0 deaths

Randomized to Hypothermia and Then Excluded

Serious events: 11 serious events

Other events: 22 other events

Deaths: 0 deaths

Randomized to Normothermia Then Excluded

Serious events: 5 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Randomized to Hypothermia and Hypothermia Maintained n=52 participants at risk Induction and maintenance of moderate hypothermia and not excluded by second set of exclusion criteria	Randomized to Normothermia and Normothermia Maintained n=45 participants at risk Induction and maintenance of normothermia and not excluded by second set of exclusion criteria	Randomized to Hypothermia and Then Excluded n=67 participants at risk Induction and maintenance of moderate hypothermia before trauma evaluation in ED and then excluded by second set of criteria	Randomized to Normothermia Then Excluded n=68 participants at risk Maintenance of normothermia before trauma evaluation in ED and then excluded by second set of criteria
Nervous system disorders Elevated Intracranial Pressure	44.2% 23/52 • Number of events 244 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	40.0% 18/45 • Number of events 128 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	11.9% 8/67 • Number of events 82 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	10.3% 7/68 • Number of events 30 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Nervous system disorders Decreased Cerebral Perfusion Pressure	5.8% 3/52 • Number of events 36 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	6.7% 3/45 • Number of events 20 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	7.5% 5/67 • Number of events 31 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/68 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Respiratory, thoracic and mediastinal disorders Pneumonia	53.8% 28/52 • Number of events 29 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	62.2% 28/45 • Number of events 33 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	25.4% 17/67 • Number of events 20 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	25.0% 17/68 • Number of events 19 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Renal and urinary disorders Urinary Tract Infection	5.8% 3/52 • Number of events 5 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	13.3% 6/45 • Number of events 6 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	7.5% 5/67 • Number of events 5 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	5.9% 4/68 • Number of events 4 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Vascular disorders Deep Vein Thrombosis	11.5% 6/52 • Number of events 6 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	13.3% 6/45 • Number of events 6 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	2.9% 2/68 • Number of events 2 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.7% 4/52 • Number of events 4 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	8.9% 4/45 • Number of events 5 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	2.9% 2/68 • Number of events 2 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Skin and subcutaneous tissue disorders Decubitus	7.7% 4/52 • Number of events 4 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	4.4% 2/45 • Number of events 2 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	6.0% 4/67 • Number of events 4 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	2.9% 2/68 • Number of events 2 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
General disorders hypotension	13.5% 7/52 • Number of events 8 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	6.7% 3/45 • Number of events 7 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	9.0% 6/67 • Number of events 10 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	5.9% 4/68 • Number of events 21 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.

Additional Information

Guy L Clifton

University of Texas Health Science Center

Phone: 2024224824

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Randomized to Hypothermia and Hypothermia Maintained n=52 participants at risk Induction and maintenance of moderate hypothermia and not excluded by second set of exclusion criteria	Randomized to Normothermia and Normothermia Maintained n=45 participants at risk Induction and maintenance of normothermia and not excluded by second set of exclusion criteria	Randomized to Hypothermia and Then Excluded n=67 participants at risk Induction and maintenance of moderate hypothermia before trauma evaluation in ED and then excluded by second set of criteria	Randomized to Normothermia Then Excluded n=68 participants at risk Maintenance of normothermia before trauma evaluation in ED and then excluded by second set of criteria
Respiratory, thoracic and mediastinal disorders Hemothorax	1.9% 1/52 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/45 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/67 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Nervous system disorders Tentorial Herniation	0.00% 0/52 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	2.2% 1/45 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/68 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Infections and infestations Blood Stream Infection	0.00% 0/52 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	4.4% 2/45 • Number of events 2 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	4.5% 3/67 • Number of events 4 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	4.4% 3/68 • Number of events 3 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Infections and infestations Catheter Positive Culture	0.00% 0/52 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	2.2% 1/45 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/52 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	2.2% 1/45 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Nervous system disorders Epidural Hemorrhage	0.00% 0/52 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/45 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/68 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
General disorders Clinical Sepsis	0.00% 0/52 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/45 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/67 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Nervous system disorders Elevated Intracranial Pressure	26.9% 14/52 • Number of events 91 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	20.0% 9/45 • Number of events 20 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	6.0% 4/67 • Number of events 7 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Nervous system disorders Decreased Cerebral Perfusion Pressure	40.4% 21/52 • Number of events 46 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	28.9% 13/45 • Number of events 34 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	6.0% 4/67 • Number of events 15 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Nervous system disorders Subdural Hemorrhage	1.9% 1/52 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	2.2% 1/45 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Nervous system disorders Intraparenchymal Hemorrhage	1.9% 1/52 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/45 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	3.8% 2/52 • Number of events 2 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/45 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	3.8% 2/52 • Number of events 2 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	4.4% 2/45 • Number of events 2 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/67 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
General disorders Hypothermia	1.9% 1/52 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/45 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
General disorders Multiple Organ Dysfunction	1.9% 1/52 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	2.2% 1/45 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/67 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Respiratory, thoracic and mediastinal disorders Hypoxemia	1.9% 1/52 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/45 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/67 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/68 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Cardiac disorders Hypotension	1.9% 1/52 • Number of events 6 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/45 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/67 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.
Cardiac disorders Cardiac Arrest	1.9% 1/52 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	2.2% 1/45 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	1.5% 1/67 • Number of events 1 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.	0.00% 0/68 • Adverse events were reported from the time of the second eligibility assessment to the time of discharge from the acute-care hospital. Generally patients were discharged from the acute care hospital within 3 months of admission.