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| ID | Type | Description | Link |
|---|---|---|---|
| P01NS038660 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.
Traumatic brain injury (TBI) causes a spectrum of cerebrovascular dysfunction, ranging from impaired pressure autoregulation to severe global ischemia (inadequate blood flow). Pressure autoregulation is the ability of an organ to maintain a constant blood flow despite changes in perfusion pressure. Impaired pressure autoregulation causes TBI patients to be more vulnerable to secondary ischemic attacks.
Erythropoietin (Epo) is a substance that is normally made by the kidneys and stimulates the production of red blood cells. It is usually given to patients to treat anemia. Scientists recently discovered that Epo also is made in the brain after injury. In animal models of TBI, the brain's production of Epo has numerous protective effects, including reducing inflammation in the brain, reducing death of brain cells, and improving blood flow to the brain. In the laboratory, the effects of this naturally-occurring, protective agent can be enhanced by giving additional amounts intravenously. Because Epo may have beneficial effects for both the injured brain and anemia, scientists are studying the effects of giving Epo to patients with severe TBI.
The primary objective of this randomized, placebo-controlled study is to determine the effect of early administration of recombinant human Epo (rhEpo), on long-term neurological outcome in patients with severe TBI. The researchers also will examine the effects of rhEpo administration on the cerebrovascular system, hemoglobin concentration, brain oxygenation, the need for blood transfusion, and on systemic complications.
This study consists of 2 parts: 1) a treatment phase, and 2) a monitoring phase. In the treatment phase, participants will be randomly assigned to 1 of 4 groups: a low or high dose rhEPO treatment group or low or high dose placebo group (control group). All other aspects of treatment during the acute post-injury phase will follow the standard treatment protocol for individuals with severe TBI. Generally the treatment phase lasts 1-2 weeks or the amount of time that is required for patients to receive treatment of their TBIs in the ICU (intensive care unit). The monitoring part of the study (which includes recording information from tests performed as part of the standard TBI treatment, as well as some additional tests performed especially for the study) lasts for up to 6 months after the TBI.
Information learned in this study may lead to knowledge about whether rhEpo improves outcomes after TBI and about the optimal hemoglobin concentration to maintain in patients with TBI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epo1 and TT10 | Active Comparator | recombinant human erythropoietin, rhEpo administration (500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion trigger of 10gm/dl |
|
| Epo1 and TT7 | Active Comparator | recombinant human erythropoietin, rhEpo administration (500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion trigger 7gm/dl |
|
| Epo2 and TT10 | Active Comparator | recombinant human erythropoietin, rhEpo administration (500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion trigger 10gm/dl |
|
| Epo2 and TT7 | Active Comparator | recombinant human erythropoietin, rhEpo administration (500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion trigger 7gm/dl |
|
| Placebo and TT10 | Placebo Comparator | Placebo administration and transfusion threshold 10 gm/dl |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human erythropoietin, rhEpo | Drug | The study design is 2x2 factorial with randomization to erythropoietin or placebo and to transfusion trigger 10 gm/dl or 7 g/dl. Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks (first 74 patients, Epo1 dosing regimen), and then the 24- and 48-hour doses were stopped for the remainder of the patients (remaining 126 patients, Epo2 dosing regimen). |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Outcome Scale | Dichotomized to favorable outcome (good recovery or moderate disability) or to unfavorable outcome (severe disability or vegetative or dead) | at 6 months after injury |
| Measure | Description | Time Frame |
|---|---|---|
| Disability Rating Scale | Disability rating scale was a secondary outcome measure for the transfusion threshold analysis. Disability rating scale ranges from 0 to 30, with 30 indicating death and 0 indicating return to normal status. | at 6 months |
| Mortality Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Robertson, MD | Professor, Department of Neurosurgery, Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine, Ben Taub General Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25058216 | Result | Robertson CS, Hannay HJ, Yamal JM, Gopinath S, Goodman JC, Tilley BC; Epo Severe TBI Trial Investigators; Baldwin A, Rivera Lara L, Saucedo-Crespo H, Ahmed O, Sadasivan S, Ponce L, Cruz-Navarro J, Shahin H, Aisiku IP, Doshi P, Valadka A, Neipert L, Waguspack JM, Rubin ML, Benoit JS, Swank P. Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial. JAMA. 2014 Jul 2;312(1):36-47. doi: 10.1001/jama.2014.6490. | |
| 27630085 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epo1/TT7 Arm | High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl |
| FG001 | Epo2/TT7 Arm | Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl |
| FG002 | Placebo/TT7 Arm | Placebo (patients received saline) and hemoglobin transfusion threshold 7 gm/dl |
| FG003 | Epo1/TT10 Arm | High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl |
| FG004 | Epo2/TT10 Arm | Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl |
| FG005 | Placebo/TT10 Arm | Placebo (patients received saline) and hemoglobin transfusion threshold 10 gm/dl |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epo1/TT7 Arm | Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 7 g/dl |
| BG001 | Epo2/TT7 Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glasgow Outcome Scale | Dichotomized to favorable outcome (good recovery or moderate disability) or to unfavorable outcome (severe disability or vegetative or dead) | Intention to treat. Multiple imputation for missing 6-month GOS data was performed assuming data were missing at random using chained equations (R, R Foundation for Statistical Computing).The imputation was based on a logistic regression model with baseline covariates. Results were aggregated over 20 imputed sets using variance formula by Rubin. | Posted | Number | participants | at 6 months after injury |
|
Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epo1 Group | Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brain death | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrospinal fluid leak | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia Robertson, MD | Baylor College of Medicine | 713-873-2792 | claudiar@bcm.edu |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
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|
| Placebo and TT7 | Placebo Comparator | Placebo administration and transfusion threshold 7 gm/dl |
|
|
| placebo | Other | an inactive substance |
|
mortality rate was a secondary outcome measure for the Epo randomization, and a primary safety outcome measure for the transfusion threshold randomization |
| up to 6 months after injury |
| Incidence of Adult Respiratory Distress Syndrome (ARDS) | development of ARDS was a primary safety outcome for the transfusion threshold randomization | within 30 days after injury |
| Incidence of Infection | occurrence of infection was a primary safety outcome for the transfusion threshold randomization | within 30 days after injury |
| Aisiku IP, Yamal JM, Doshi P, Benoit JS, Gopinath S, Goodman JC, Robertson CS. Plasma cytokines IL-6, IL-8, and IL-10 are associated with the development of acute respiratory distress syndrome in patients with severe traumatic brain injury. Crit Care. 2016 Sep 15;20:288. doi: 10.1186/s13054-016-1470-7. |
| 26496111 | Derived | Yamal JM, Benoit JS, Doshi P, Rubin ML, Tilley BC, Hannay HJ, Robertson CS. Association of transfusion red blood cell storage age and blood oxygenation, long-term neurologic outcome, and mortality in traumatic brain injury. J Trauma Acute Care Surg. 2015 Nov;79(5):843-9. doi: 10.1097/TA.0000000000000834. |
| 26491799 | Derived | Aisiku IP, Yamal JM, Doshi P, Rubin ML, Benoit JS, Hannay J, Tilley BC, Gopinath S, Robertson CS. The incidence of ARDS and associated mortality in severe TBI using the Berlin definition. J Trauma Acute Care Surg. 2016 Feb;80(2):308-12. doi: 10.1097/TA.0000000000000903. |
| 24686108 | Derived | Yamal JM, Robertson CS, Rubin ML, Benoit JS, Hannay HJ, Tilley BC. Enrollment of racially/ethnically diverse participants in traumatic brain injury trials: effect of availability of exception from informed consent. Clin Trials. 2014 Apr;11(2):187-94. doi: 10.1177/1740774514522560. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 7 g/dl
| BG002 | Placebo/TT7 Arm | Patients received saline and transfused to keep hemoglobin concentration at least 7 g/dl |
| BG003 | Epo1/TT10 Arm | Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 10 g/dl |
| BG004 | Epo2/TT10 Arm | Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 10 g/dl |
| BG005 | Placebo/TT10 Arm | Patients received saline and transfused to keep hemoglobin concentration at least 10 g/dl |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Prehospital hypotension | Number | participants |
|
| Prehospital hypoxia | Number | participants |
|
| Mechanism of injury | Number | participants |
|
| Injury Severity Score | Injury Severity Score describes the severity of all traumatic injuries. The score ranges from 0 to 75, with a higher score indicating a more severe injury. | Median | Inter-Quartile Range | units on a scale |
|
| IMPACT probability of poor outcome | Mean | Standard Deviation | probability of poor outcome |
|
| Motor component of Glasgow Coma Score | The motor component of the Glasgow Coma Score describes the motor response. The scale ranges from 1-6 (1=no response, 2=decerebrate posturing, 3=decorticate posturing, 4=withdrawal response, 5=localizing response, 6=following commands) with a higher score indicating better performance. | Number | participants |
|
| Sum Glasgow Coma Score | The Sum Glasgow Coma Score sums the three components of the neurological examination (eye, verbal, and motor responses). The score ranges from 3 to 15 with 3 indicating no response, and 15 indicating normal response. | Number | participants |
|
| Pupil reactivity | Number | participants |
|
| Marshall CT scan category | Marshall CT scan category is a classification system for traumatic brain injury. Diffuse injury 1 is a normal scan. Diffuse injury 2 has some abnormalities but basal cisterns are present. Diffuse injury 3 has basal cistern compression but no midline shift. Diffuse injury 4 has midline shift. Mass lesions include hematomas and contusions of at least 25 ml in volume. | Number | participants |
|
| Presence of subarachnoid hemorrhage | Number | participants |
|
| Presence of epidural hematoma | Number | participants |
|
| Hemoglobin concentration | Median | Inter-Quartile Range | g/dl |
|
| Glucose concentration | Median | Inter-Quartile Range | mmol/L |
|
| Surgery on admission | Number | participants |
|
| Epo2 Group |
Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined) |
| OG002 | Placebo Group | Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined) |
| OG003 | TT7 Group | Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined) |
| OG004 | TT10 Group | Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined) |
|
|
|
| Secondary | Disability Rating Scale | Disability rating scale was a secondary outcome measure for the transfusion threshold analysis. Disability rating scale ranges from 0 to 30, with 30 indicating death and 0 indicating return to normal status. | Intention to treat analysis | Posted | Median | Inter-Quartile Range | units on a scale | at 6 months |
|
|
|
|
| Secondary | Mortality Rate | mortality rate was a secondary outcome measure for the Epo randomization, and a primary safety outcome measure for the transfusion threshold randomization | Intention to treat analysis | Posted | Number | participants | up to 6 months after injury |
|
|
|
|
| Secondary | Incidence of Adult Respiratory Distress Syndrome (ARDS) | development of ARDS was a primary safety outcome for the transfusion threshold randomization | Intention to treat analysis | Posted | Number | participants | within 30 days after injury |
|
|
|
|
| Secondary | Incidence of Infection | occurrence of infection was a primary safety outcome for the transfusion threshold randomization | Intention to treat analysis | Posted | Number | participants | within 30 days after injury |
|
|
|
|
| 29 |
| 38 |
| 34 |
| 38 |
| EG001 | Epo2 Group | Patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined) | 50 | 64 | 57 | 64 |
| EG002 | Placebo Group | Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined) | 78 | 98 | 87 | 98 |
| EG003 | TT7 Group | Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined) | 85 | 99 | 85 | 99 |
| EG004 | TT10 Group | Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined) | 93 | 101 | 93 | 101 |
| Brain tissue hypoxia | Nervous system disorders | Systematic Assessment | Brain tissue pO2 less than 10 mmHg for more than 10 minutes |
|
| delayed or recurrent intracranial hemorrhage | Nervous system disorders | Systematic Assessment | new hematoma or increase in hematoma after initial CT scan, or recurrence of a hematoma after surgical evacuation |
|
| hydrocephalus | Nervous system disorders | Systematic Assessment |
|
| intracranial hypertension | Nervous system disorders | Systematic Assessment | intracranial hypertension requiring treatment with mannitol, barbiturate coma, decompressive craniectomy or that resulted in neurological deterioration or death |
|
| meningitis or ventriculitis | Nervous system disorders | Systematic Assessment |
|
| wound dehiscence | Nervous system disorders | Systematic Assessment |
|
| stroke | Nervous system disorders | Systematic Assessment |
|
| Lower extremity deep venous thrombophlebitis | Vascular disorders | Systematic Assessment |
|
| acute myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| cardiac arrest with CPR | Cardiac disorders | Systematic Assessment |
|
| Gangrene of extremities | Vascular disorders | Systematic Assessment |
|
| Hypotension due to barbiturate coma | Cardiac disorders | Systematic Assessment |
|
| Upper extremity deep venous thrombophlebitis | Vascular disorders | Systematic Assessment |
|
| Pulmonary embolus | Cardiac disorders | Systematic Assessment |
|
| Shock | Cardiac disorders | Systematic Assessment | Hypotension (mean blood pressure less than 60 mmHg) requiring treatment with pressors |
|
| Abdominal compartment syndrome | Gastrointestinal disorders | Systematic Assessment |
|
| incarcerated inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| peritonitis | Gastrointestinal disorders | Systematic Assessment |
|
| Severe anemia | Blood and lymphatic system disorders | Systematic Assessment | Hemoglobin concentration less than 6 gm/dl |
|
| Other severe hematologic disorder | Blood and lymphatic system disorders | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | Infections and infestations | Systematic Assessment |
|
| Wound infection, non-central nervous system | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Septic shock | Infections and infestations | Systematic Assessment |
|
| Diabetes insipidus | Endocrine disorders | Systematic Assessment |
|
| Carotid cavernous fistula | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Infected eye injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hemothorax | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Osteomyelitis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rhabdomyalysis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tongue laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| internal jugular vein injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Severe metabolic acidosis | Renal and urinary disorders | Systematic Assessment |
|
| Severe mixed acid-base disorder | Renal and urinary disorders | Systematic Assessment |
|
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Airway obstruction post-extubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Severe atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Electrolyte disturbance | Renal and urinary disorders | Systematic Assessment |
|
| Brain tissue hypoxia | Nervous system disorders | Systematic Assessment |
|
| Delayed or recurrent intracranial hematoma | Nervous system disorders | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
|
| Intracranial hypertension | Nervous system disorders | Systematic Assessment |
|
| Pneumocephalus | Nervous system disorders | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Subgaleal cerebrospinal fluid collection | Nervous system disorders | Systematic Assessment |
|
| Lower extremity deep venous thrombophlebitis | Vascular disorders | Systematic Assessment |
|
| Atrial arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Hypotension from barbiturate coma | Cardiac disorders | Systematic Assessment |
|
| Upper extremity deep vein thrombophlebitis | Vascular disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Upper GI bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated transaminases | Hepatobiliary disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Other hematologic disorder | Blood and lymphatic system disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Bacteremia | Infections and infestations | Systematic Assessment |
|
| Wound infection, non-central nervous system | Infections and infestations | Systematic Assessment |
|
| Diabetes insipidus | Endocrine disorders | Systematic Assessment |
|
| Diffuse edema | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | Systematic Assessment |
|
| Hypothermia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Bleeding complicating a procedure | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Decubitis ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Exposure keratoconjunctivitis | Eye disorders | Systematic Assessment |
|
| Rhabdomyalysis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| acute renal dysfunction | Renal and urinary disorders | Systematic Assessment |
|
| Metabolic acidosis | Renal and urinary disorders | Systematic Assessment |
|
| Mixed acid-base abnormality | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Airway obstruction post-extubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tracheobronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Febrile transfusion reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Electrolyte imbalance | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Survived |
|
| No |
| Superiority or Other |
| Log Rank | .72 | No | Superiority or Other |