UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036432
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email abhishekkt90@gmail.com

Sponsor
Institute Central Institute of Orthopaedics(CIO), Safdarjung Hospital and VMMC, New Delhi-110029
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041506

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.