Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT01014403
Eligibility Criteria:
Inclusion Criteria:
1\. Male and female patients admitted to the ETMC SICU with TBI who speak English or Spanish.
Exclusion Criteria:
1. Epidural or subdural hematoma \> 8mm.
2. Intraparenchymal contusion \>2 cm
3. Multiple contusions w/in one lobe
4. Subarachnoid hemorrhage in basilar or supracellar cistern and positive CTA
5. Increased TBI on 24 hr post-injury CT
6. Spinal canal hematoma
7. Nonoperative mgmt of American Association for the Surgery of Trauma (AAST) Grade IV or higher organ injury
8. Gastrointestinal hemorrhage
9. Ongoing bleeding from a pelvic fracture
10. Anticipated open reduction of long bone or pelvic fracture within study period.
11. Intracranial pressure (ICP) \>20 mmHg
12. Coagulopathy consisting of International Normalized Ratio (INR)\>1.5 or platelet count \<50,000
13. Expect brain death/discharge in 48 hrs
14. Pre-existing dialysis dependence
15. Documented DVT at time of admission
16. Prisoners
17. Pregnancy
18. Age \<18 years
19. Terminally ill patients
20. Anticoagulant use at time of injury
21. Inability to gain consent from patient or legal next-of-kin in instance of TBI, intoxication, or psychiatric diagnoses
22. Documented history of heparin allergy
23. Initial head CT \>6 hours post-injury
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01014403
Study Brief:
Protocol Section:
NCT01014403