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A prospective study focusing on SCPP and ISP refined therapy to improve outcomes in patients with acute traumatic spinal cord injury

A prospective study focusing on refined therapy with SCPP and ISP to improve prognosis in patients with acute traumatic spinal cord injury - Neurosurgery

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081827
Enrollment
Unknown
Registered
2024-03-13
Start date
2023-11-01
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal cord injury

Interventions

Control group:conventional laminectomy decompression +ISP monitoring tube implantation.
Experimental Group :conventional laminectomy decompression +ISP monitoring tube insertion + dural enlargement a plastic surgery.

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Incomplete TSCI, rated B-D by the American Spinal Cord Injury Association (ASIA); 2) Age 18-70 years old; 3) The time interval between TSCI and operation should be within 72 hours; 4) Acute spinal cord injury that the investigator determined required surgery; 5) Be able to understand the whole process of this study, voluntarily participate in and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Surgical treatment is not necessary or cannot be performed according to the investigator's judgment or for other reasons. 2) There is a transspinal injury or complete rupture of the spinal cord. 3) Traumatic brain injury accompanied by visual or imaging diagnosis, such as intracranial hemorrhage. 4) Other acute and chronic diseases that cause neurological impairment (e.g., multiple sclerosis, Glenba Leigh syndrome, etc.). 5) Patients with body temperature below 35?. 6) Hemoglobin < Patients with 90g/L. 7) It is difficult to complete the research because of coma, mental illness or other reasons. 8) History of substance abuse or dependence. 9) Allergic to macromolecular drugs or have a history of severe drug allergy. 10) HIV and syphilis infection or active hepatitis B and C. 11) The patient has a history of serious diseases of the heart, lung, liver, kidney and other organ systems, with discomfort judged by the investigator Patients participating in clinical trials. 12) With active tumor or a history of invasive tumor treatment within 3 years. 13) The researcher believes that it is not suitable to participate in this clinical study for other reasons.

Design outcomes

Primary

MeasureTime frame
Improved Barthel index;

Secondary

MeasureTime frame
SCPP changes;ISP changes;American Spinal Cord Injury Association rating;American Spinal Cord Injury Association sensory score;American Spinal Cord Injury Association exercise score;

Countries

China

Contacts

Public ContactWei Meng

The First Affiliated Hospital of Nanchang University

5703914@qq.com+86 189 0791 3311

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026