| CTRI Number |
CTRI/2020/02/023146 [Registered on: 06/02/2020] Trial Registered Prospectively |
| Last Modified On: |
31/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Hypothermia in Acute Spinal cord Injury |
|
Scientific Title of Study
|
Evaluation of Outcome of Modest Hypothermia in Acute Spinal Cord Injury: A randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashasth B S |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of orthopedics, Nehru hospital, PGIMER, sector 12, Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09480771647 |
| Fax |
|
| Email |
bsp1493@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvdeep Singh Dhatt |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Department of orthopedics, Nehru hospital, PGIMER, sector 12, Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09815126600 |
| Fax |
|
| Email |
sdhatt@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashasth B S |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of orthopedics, Nehru hospital, PGIMER, sector 12, Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09480771647 |
| Fax |
|
| Email |
bsp1493@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopedics, Postgraduate Institute Of Medical education and Research, sector 12, Chandigarh-160012 |
|
|
Primary Sponsor
|
| Name |
Department of Orthopedics PGIMER |
| Address |
Room number 15 B Block Level 1 Nehru Hospital PGIMER sector 12 Chandigarh India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prashasth B S |
Advance Trauma Centre |
Advance Trauma Centre, Department of Orthopedics,Division Trauma,room number 22, PGIMER, sector 12, Chandigarh, India
Chandigarh
CHANDIGARH |
09480771647
bsp1493@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Postgraduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S122||Fracture of third cervical vertebra, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypothermia |
core body temperature of patient will be kept at 33 celcius for 24 hours prior to surgical fixation |
| Comparator Agent |
normothermia |
core body temperature of patient will be kept at 37 celcius for 24 hours prior to surgical fixation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurological improvement by ASIA scoring |
Day1, Day7, Day14, Day42, Day84, Day168 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain Sensitivity |
Day1, Day7, Day14, Day42, Day84, Day168 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
4. Martirosyan NL, Patel AA, Carotenuto A, Kalani MY, Bohl MA, Preul MC, et al. The role of therapeutic hypothermia in the management of acute spinal cord injury. Clin neurol and neurosurg. 2017;154:79-88.
Dietrich WD. Therapeutic hypothermia for spinal cord injury. Crit care med. 2009;37:S238-42 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In our study we hypothesize that modest hypothermia(33oC)
for a duration of 24 hours in patients
with acute traumatic spinal cord injuries is neuroprotective and thus limits the neurological dysfunction
caused by the trauma . Hypothermia suppresses the inflammatory processes
and reduction in free radicals like super oxide, nitric oxide and hydroxyl
radicals are believed to be instrumental in preventing neuronal damage after
brain and spinal cord injury. |