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 @ 3:43 AM
Ignite Modification Date:
2025-12-25 @ 3:43 AM
NCT ID:
NCT03231202
Eligibility Criteria:
Inclusion Criteria:
* blunt splenic injury OIS grade 4 or 5
* Adult trauma patients (according to local definitions)
* Present hemodynamically normal as judged by the responsible trauma consultant surgeon and eligible for NOM
* Randomised within 48 hours of injury
* Written informed consent is obtained
Exclusion Criteria:
* Hemodynamically compromised (not suitable for NOM)
* Needing transfusions
* CT shows evidence of significant contrast extravasation
* Other indications for laparotomy
* Prisoners
* Pregnant
* \>80 years old
* Penetrating injury
* Contraindication to iv contrast
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT03231202
Study Brief:
Protocol Section:
NCT03231202