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A multi-center, single-blind, randomized controlled study on the clinical efficacy and safety of low-dose methylprednisolone in acute spinal cord injury ( SCI ).

A multi-center, single-blind, randomized controlled study on the clinical efficacy and safety of low-dose methylprednisolone in acute spinal cord injury ( SCI ).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114217
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Acute spinal cord injury

Interventions

Experimental Group:0.9 % sodium chloride solution 100ml compatibility methylprednisolone 40mg ivgtt Q12h, continuous use of 7 days
Control group:0.9 % sodium chloride solution 100ml ivgtt Q12h, continuous use for 7 days

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Acute spinal cord injury in the neck or chest; 2. The time from injury to hospital admission is less than 24 hours; 3. All patients underwent spinal canal decompression surgery. 4. No surgery-related complications occurred (such as internal fixation complications, intraspinal hematoma, iatrogenic spinal cord injury, etc.); 5. The patient's ASIA neurological function classification at admission was B, C, or D.

Exclusion criteria

Exclusion criteria: 1.Pregnant women; 2. People allergic to Methylprednisolone; 3. There were already diseases such as pulmonary infection and gastrointestinal bleeding before admission; 4. Hormone drugs had been used in other institutions before admission; 5. Patients who had obvious neurological dysfunction or spinal cord function impairment before spinal cord injury; 6. There are related diseases that have a significant impact or may affect the recovery of neurological function as the disease progresses; 7. Patients with multiple injuries such as severe traumatic brain injury.

Design outcomes

Primary

MeasureTime frame
The change in the ASIA neurological function score of the patient 12 months after injury compared with the baseline (at admission);

Secondary

MeasureTime frame
The change in the ASIA neurological function grade of the patient 12 months after injury compared to the baseline (at admission);The changes in the ASIA neurological function score of the patient from baseline (at admission) at 3 and 6 months after injury and the neurological function Change value of function level;The incidence of perioperative complications;

Countries

China

Contacts

Public ContactLiu Zhili

The First Affiliated Hospital of Nanchang University

zhili-liu@ncu.edu.cn+86 139 7007 2969

Outcome results

None listed

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