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Table 1 Inclusion and exclusion criteria for the Erythropoietin in Traumatic Brain Injury (EPO-TBI) trial

From: Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury

Inclusion

Patients with non-penetrating moderate (Glasgow Coma Score (GCS) 9–12) or severe (GCS 3–8) traumatic brain injury admitted to an ICU who:

 

1. Are ≥15 to ≤65 years of age*

 

2. Are <24 hours since primary traumatic injury

 

3. Are expected to stay ≥48 hours

 

4. Have a haemoglobin not exceeding the upper limit of the applicable normal reference range in clinical use at the treating institution**

 

5. Have written informed consent from legal surrogate

Exclusion

Patients are excluded from the study if any of the following criteria apply#:

 

1. GCS = 3 and fixed dilated pupils

 

2. History of deep vein thrombosis, pulmonary embolism or other thromboembolic event

 

3. A chronic hypercoagulable disorder, including known malignancy

 

4. Treatment with erythropoietin in the last 30 days

 

5. First dose of study drug unable to be given within 24 hours of primary injury

 

6. Pregnancy or lactation or 3 months post-partum

 

7. Uncontrolled hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg)

 

8. Acute myocardial infarct within the past 12 months

 

9. Past history of epilepsy with seizures in past 3 months

 

10. Expected to die imminently (<24 hours)

 

11. Inability to perform lower limb ultrasounds

 

12. Known sensitivity to mammalian cell-derived products

 

13. Hypersensitivity to the active substance or to any of the additives

 

14. Pure red cell aplasia

 

15. End-stage renal failure (receives chronic dialysis)

 

16. Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome

 

17. Spinal cord injury

 

18. Treatment with any investigational drug within 30 days before enrolment

 

19. The treating physician believes it is not in the best interests of the patient to be randomised to this trial

  1. *6 sites had minimum age 15 years, 13 sites minimum age 16 years and 10 sites minimum age 18 years.
  2. **< 140 g/L at Johannes Gutenberg-Universtität, Mainz Germany.
  3. **<148 g/L for males and < 135 g/L for females at Royal Adelaide Hospital, Adelaide Australia.
  4. #Additional exclusion criteria at Johannes Gutenberg-Universtität, Mainz Germany. Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >90 mm Hg), morbid obesity, coronary artery disease, peripheral arterial occlusive disease, vascular disease of the carotid arteries, cerebrovascular disorders, recent stroke, contraindications against prophylaxis of DVT or an increased risk for DVT (e.g. with additional trauma and/or operations, severe varicose veins, severe smokers, intake of oral contraceptives, infections and inflammation).
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