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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT01251003
Eligibility Criteria:
Inclusion Criteria:
* Hospital admission Glasgow Coma Score between 3 and 12 at the time of injury
* Injury occurring 6 to 18 months prior to study cord blood infusion (+/- 30 days)
* Ability of child and caregiver to travel to Houston, and stay for at least 4 days, and to return for all Follow-up visits
* Ability of child to understand (and speak) English
* Child's own cord blood banked at Cord Blood Registry
Exclusion Criteria:
* Inability to obtain all pertinent medical records, including pertinent physician notes, laboratory findings, and radiographic images, related to the original injury, hospitalization and rehabilitation
* Recent radiographic evidence of extensive stroke as evidenced by \>100ml lesion
* Pre-injury history of seizure disorder and/or neurological impairment
* Obliteration of perimesencephalic cistern on initial head CT/MRI
* Initial hospital Intracranial Pressure (ICP) \> 40
* Unhealed fractures or wounds including osteomyelitis
* Pneumonia, or chronic lung disease requiring oxygen
* Spinal cord injury as diagnosed by CT or MR imaging or by clinical findings
* Cord blood sample contamination
* Participation in a concurrent intervention study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
17 Years
Study:
NCT01251003
Study Brief:
Protocol Section:
NCT01251003