Hypothermia in Acute Spinal cord Injury

Phase 1

Not yet recruiting

• Conditions: Fracture of third cervical vertebra,

• Registration Number: CTRI/2020/02/023146
• Lead Sponsor: Department of Orthopedics PGIMER

Brief Summary

In our study we hypothesize that modest hypothermia(33oC)for a duration of 24 hours in  patientswith acute traumatic spinal cord injuries is neuroprotective  and thus limits the neurological dysfunctioncaused by the trauma . Hypothermia suppresses the inflammatory processesand reduction in free radicals like super oxide, nitric oxide and hydroxylradicals are believed to be instrumental in preventing neuronal damage afterbrain and spinal cord injury.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-01-31
• Study Start: 2020-10-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1.Patient of age group 18 – 65 years.
• 2.Patients with closed spinal cord injury.
• 3.Patients with GCS 15/15.
• 4.AIS score A 5.Patient willing/giving consent to take part in the study.

Exclusion Criteria

• 1.Age <18 or >65 years 2.AIS score B, C , D or E 3.Hyperthermia >38.5 0C on admission 4.Polytrauma patients 5.History of Severe bleeding, Coagulopathy, Thrombocytopenia 6.History of cardiac disease 7.Pancreatitis 8.History of Raynaud syndrome 9.Complete Spinal cord transection by MRI on Admission 10.Patients intubated/ sedated prior to neurological examination 11.Patients presenting to the hospital after 24 hours of injury.
• 12.Patient not willing to participate in study/ not giving consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurological improvement by ASIA scoring	Day1, Day7, Day14, Day42, Day84, Day168

Secondary Outcome Measures

Name	Time	Method
Pain Sensitivity	Day1, Day7, Day14, Day42, Day84, Day168

Trial Locations

Locations (1)

Advance Trauma Centre; 🇮🇳 Chandigarh, CHANDIGARH, India

Advance Trauma Centre

🇮🇳Chandigarh, CHANDIGARH, India

Prashasth B S

Principal investigator

09480771647

bsp1493@gmail.com