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CTRI Number  CTRI/2014/09/004949 [Registered on: 01/09/2014] Trial Registered Prospectively
Last Modified On: 13/07/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to find out incidence of blood clot formation in high risk patients undergoing spine surgery.  
Scientific Title of Study   A Prospective,cross sectional study to find out incidence of deep vein thrombosis in high risk patients undergoing spine surgery.  
Trial Acronym  No 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharat R Dave  
Designation  Director Consultant Spine Surgeon Institutional Head  
Affiliation  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine Hospital and Research Institute Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad
NA
Ahmadabad
GUJARAT
380006
India 
Phone  07926568174  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Krishnan 
Designation  Consultant Spine Surgeon Co investigator 
Affiliation  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine Hospital and Research Institute Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad
NA
Ahmadabad
GUJARAT
380006
India 
Phone  07926565657  
Fax  07926408174  
Email  drajaykrishnan@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shaunak C Dudhia 
Designation  Consultant Physician and Cardiologist 
Affiliation  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine Hospital and Research Institute Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad
Dudhia Medical and Children Hospital Khadia Ahmedabad
Ahmadabad
GUJARAT
380006
India 
Phone  07926565757  
Fax  07926408174  
Email  drscdudhia@gmail.com  
 
Source of Monetary or Material Support  
Non Funded Study  
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine Hospital and Research Institute nr nagari hospital Nr Hindi Rashtrabhasha College Mithakhali Ahmedabad Gujarat India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Stavya Spine Hospital and Research Institute   Nr Nagari Hospital Nr Hindi Rashtrabha College Mithakhali Ellisbridge Ahmedabad 380006 Gujarat  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat R Dave  Stavya Spine Hospital and Research Institute  Spine Research Wing Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad
Ahmadabad
GUJARAT 		 07926568174
07926408174
brd_172@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Stavya Spine Hospital and Research Institute Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Deep Vein Thrombosis in High risk patients undergoing spine Surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.99 Year(s)
Gender  Both 
Details  Patients are included in the study if they are undergoing spine surgery at Stavya Spine Hospital and Research Institute with any of the following criteria:
1.Malignancy: present or past within 6 months
2.Hematological disorder (Thrombophilia, High factor VIII levels, antithrombin deficiency, protein c deficiency, protein s deficiency, high fibrinogen levels, high factor IX levels, high factor XI levels, leukemia, thrombocytosis)
3.Immobilisation- 72 hours
4.Past history of DVT
5.Varicose veins
6.Spine infection
7.Obesity (BMI > 30)
8.Age > 65 years
9.Myelopathy with Nurick’s Grade 3 or more than 3
10.ASIA Impairment scale (AIS) grade A/B/C
11.Long duration of surgery > 2 hours

 
 
ExclusionCriteria 
Details 
Patients are excluded from participating in this study if any of the following criteria are met:

1.Patient not fulfilling inclusion criteria
2.Patient not willing to participate in the study or not willing to sign the consent form.
3.Active local infection of lower limb like cellulitis.
4.Active hepatitis (receiving medical treatment within two years);
5.Pregnant or planning to become pregnant during study period;
6.Patients who have limited life expectancy due to significant medical comorbidities.
7.Known or documented history of communicable disease, including AIDS or HIV;
8.Immunologically suppressed, history of Paget’s disease, osteomalacia, or any other metabolic bone disease;
9.Active hepatitis (receiving medical treatment within two years)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Positive venous color doppler study of lower limbs for diagnosing deep vein thrombosis.   The assessment will be made preoperatively on admission and approximate 6 weeks after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/09/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a single centre,prospective,observational study. In this study, all the high risk patients undergoing spine surgery will be screened for DVT and followed upto 6 weeks following surgery.
A total of two hundred and fifty ( 250) patients, who met the inclusion exclusion criteria will be enrolled in the study.
Patients will be screened for deep vein thrombosis by venous colour doppler of lower limbs, and at 6 weeks following surgery.
There will be 2 years maximum patient recruitment period.
The total duration of this study is expected to be upto 6 weeks for the patient enrolled.
All patients with confirmed DVT will receive standard therapeutic anticoagulant therapy or intervention as will be advised by the vascular surgeons and physician.
 
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