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:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT01589393
Eligibility Criteria:
Inclusion Criteria:
1\. Multi-system trauma patients referred to the trauma service with a non-progressing tICH documented on 24-hour repeat head CT scan
Exclusion Criteria:
1. Less than 16 years of age
2. Unexpected to survive or to remain in hospital \>72 hours
3. Known malignancy under active care at time of admission
4. Known DVT, PE, or other condition requiring anticoagulation at time of admission
5. Coagulopathy (defined as international normalized ratio (INR) values \>1.5 times the upper limit of normal, or partial thromboplastin time (PTT) values \>1.5 times the upper limit of normal) at 24 hours after admission
6. Platelet count \<75 x 109/L at 24 hours after admission
7. Bilateral lower limb amputation
8. History of allergy to heparin or suspected or proven HIT
9. Limitation of life support or palliative care
10. Prior enrolment in this trial or currently in a confounding randomized trial
11. Pregnancy
12. Study drug (LMWH or placebo) not administered within 36-48 hours post-injury
13. Grade V liver or splenic injuries that have not received definitive care (e.g. embolization, surgical intervention) within 36-48 hours after injury
14. Persistent intracranial pressure \>20 mm Hg
15. Spinal subdural haematoma or spinal epidural haematoma
16. Intracranial haemorrhage progression on 24-hour repeat CT head scan
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01589393
Study Brief:
Protocol Section:
NCT01589393