| CTRI Number |
CTRI/2018/11/016318 [Registered on: 12/11/2018] Trial Registered Prospectively |
| Last Modified On: |
10/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the prevalence of deep vein thrombosis in elderly patients undergoing surgery for hip fracture |
|
Scientific Title of Study
|
A study to evaluate prevalence of deep vein thrombosis in elderly patients undergoing surgery for hip fracture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi Kiran |
| Designation |
Senior Professor |
| Affiliation |
Pt. B.D. Sharma P.G.I.M.S. Rohtak |
| Address |
Pt. B.D. Sharma P.G.I.M.S. Rohtak, Department of anaesthesiology
Rohtak
HARYANA
124001
India |
| Phone |
9416763899 |
| Fax |
|
| Email |
drshashi64@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Kiran |
| Designation |
Senior Professor |
| Affiliation |
Pt. B.D. Sharma P.G.I.M.S. Rohtak |
| Address |
Pt. B.D. Sharma P.G.I.M.S. Rohtak, Department of anaesthesiology
HARYANA
124001
India |
| Phone |
9416763899 |
| Fax |
|
| Email |
drshashi64@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil guliyani |
| Designation |
junior resident |
| Affiliation |
Pt. B.D. Sharma P.G.I.M.S. Rohtak |
| Address |
Pt. B.D. Sharma P.G.I.M.S. Rohtak, Department of anaesthesiology
Rohtak
HARYANA
124001
India |
| Phone |
9079175289 |
| Fax |
|
| Email |
nikhil27guliyani1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology. Pt. B.D. Sharma institute of medical sciences rohtak |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology |
| Address |
PGIMS, UHS Rohtak |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Shashi Kiran |
Department of anaesthesiology PGIMS Rohtak |
Department of anaesthesiology,Pt. B.D. Sharma institute of medical sciences, Rohtak, haryana
Rohtak
HARYANA |
9416763899
drshashi64@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S722||Subtrochanteric fracture of femur, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patients of either sex aged more than 65 years of age belonging to ASA I to III scheduled to undergo surgery for hip fracture |
|
| ExclusionCriteria |
| Details |
fractures around implant and pathological fracture.
previous venous thromboembolic diseases.
known coagulation disorder or patients already on anticoagulation therapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate prevalence of deep vein thrombosis in elderly patients undergoing surgery for hip fracture using colour doppler ultrasonography. |
To evaluate prevalence of deep vein thrombosis in elderly patients undergoing surgery for hip fracture using colour doppler ultrasonography, time point 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate prevalence of deep vein thrombosis in elderly patients undergoing surgery for hip fracture using colour doppler ultrasonography. |
1year |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2018 |
| 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="0"
Months="7"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective study to evaluate deep vein thrombosis in elderly patients undergoing surgery for hip fracture. we will see compressibility of femoral, popliteal, tibial and peroneal veins as well as augmentation of flow with Valsalva in femoral and with calf compression in popliteal veins. |