UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036432 |
|---|---|
| Receipt number | R000041506 |
| Scientific Title | EFFECT OF PROPHYLAXIS FOR DEEP VENOUS THROMBOSIS IN TRAUMATIC SPINAL CORD INJURY |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2019/04/07 03:22:51 |
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Basic information
Public title
EFFECT OF PROPHYLAXIS FOR DEEP VENOUS THROMBOSIS IN TRAUMATIC SPINAL CORD INJURY
Acronym
DVTSCI
Scientific Title
EFFECT OF PROPHYLAXIS FOR DEEP VENOUS THROMBOSIS IN TRAUMATIC SPINAL CORD INJURY
Scientific Title:Acronym
DVTSCI
Region
| Asia(except Japan) |
Condition
Condition
DEEP VENOUS THROMBOSIS IN TRAUMATIC SPINAL CORD INJURY
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of prophylaxis with low molecular weight heparin for deep venous thrombosis in traumatic spinal cord injury patients in a tertiary care hospital in Indian setting.
Basic objectives2
Others
Basic objectives -Others
To identify the risk factors for DVT in traumatic spinal cord injury patients in a tertiary care hospital in Indian setting.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Patients clinical assessment for DVT using WELL SCORE along with d dimer
assay every, 2 weeks after getting into either
study or control group. USG doppler
to rule out DVT (considered the gold standard in the study).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment | Maneuver |
| Other |
Interventions/Control_1
Intervention(n=50):
Subcutaneous low molecular weight heparin (enoxaparin 40 mg/day) given for 2 months
Physiotherapy of all joints
Massage
Interventions/Control_2
Control(n=50):
Physiotherapy of all joints
Massage
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Cervical spinal cord injury patient with quadriplegia
2. Thoracolumbar spinal cord injury with paraplegia
3. Age >18 years
Key exclusion criteria
1. Incomplete spinal cord injury patient
2. Spinal cord injury without neurological deficit
3. Pathological fractures of the spine
4. Congenital deformity of the spine
5. Localised infection in extremities
6. Derranged PT/INR Values
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Dr. Ramesh |
| Middle name | |
| Last name | Kumar |
Organization
Safdarjung Hospital and
Vardhman Mahavir Medical College, MoHFW, GoI
Division name
Central Institute of Orthopaedics(CIO)
Zip code
110029
Address
Central Institute of Orthopaedics(CIO), Safdarjung Hospital and VMMC, New Delhi-110029
TEL
+911126192467
drkumarramesh@gmail.com
Public contact
Name of contact person
| 1st name | Dr Abhishek |
| Middle name | |
| Last name | Tiwari |
Organization
Safdarjung Hospital and Vardhman Mahavir Medical College, MoHFW, GoI
Division name
Central Institute of Orthopaedics(CIO)
Zip code
110029
Address
Central Institute of Orthopaedics(CIO), Safdarjung Hospital and VMMC, New Delhi-110029
TEL
+911126192467
Homepage URL
abhishekkt90@gmail.com
Sponsor or person
Institute
Central Institute of Orthopaedics(CIO), Safdarjung Hospital and VMMC, New Delhi-110029
Institute
Department
Personal name
Funding Source
Organization
Safdarjung Hospital and Vardhman Mahavir Medical College, MoHFW, GoI
Central Institute of Orthopaedics(CIO)
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Indian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Safdarjung Hospital and Vardhman Mahavir Medical College, MoHFW, GoI
Address
Institutional Ethics Committee, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi-110029
Tel
+911126263708
ethicscommitteevmmc@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Central Institute of Orthopaedics(CIO), Safdarjung Hospital and Vardhman Mahavir Medical College, MoHFW, GoI
Affiliated to
Guru Gobind Singh Indraprastha University, New Delhi, India
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
Hundred patients were randomly divided into study group and control group with 50 patients each. Demographics of all the patients who were included in the study group as well as control group were noted and the patient underwent clinical assessment for DVT and D-Dimer assay and colour doppler were done. All the patients included in the study underwent surgical decompression and fixation.
Results date posted
| 2019 | Year | 04 | Month | 07 | Day |
Results Delayed
Results Delay Reason
No Delay
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Patient attending Safdarjung OPD & Emergency
Assessed for eligibility
Excluded
Not meeting inclusion criteria
Decline to participate
d-dimer positive or known case of DVT
Raised PT/INR
Randomised(n=100)
Study Group (n=50)
LMWH(S/C enoxaparin) given
Physiotherapy of all joints
Massage
Control group(n=50)
Physiotherapy of all joints
Massage
Well score and d-dimer assay done for both groups.
Study Group:
Both negative: Continue LMWH with physiotherapy and massage for 2 months, followed by well score and d-dimer assay
Both or either of two positive: Color doppler
Color doppler positive: DVT Confirmed
Color doppler negative: Continue LMWH with physiotherapy and massage for 2 months, followed by well score and d-dimer assay
Control Group:
Both negative: Continue physiotherapy and massage for 2 months, followed by well score and d-dimer assay
Both or either of two positive: Color doppler
Color doppler positive: DVT Confirmed
Color doppler negative: Continue physiotherapy and massage for 2 months followed by well score and d-dimer assay
Adverse events
NA
Outcome measures
Patients clinical assessment for DVT using WELL SCORE along with d-dimer assay every, 2 weeks after getting into either study or control group. USG doppler to rule out DVT and it was considered the gold standard.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was approved by the institutional ethical committee, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi,India and bears number : IEC/VMMC/SJH/THESIS/NOVEMBER-/2016/656
The study was conducted as a thesis for MS(Orthopaedics) degree, and has been submitted to Guru Gobind Singh Indraprastha University, New Delhi.
Management information
Registered date
| 2019 | Year | 04 | Month | 07 | Day |
Last modified on
| 2019 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041506
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