| CTRI Number |
CTRI/2021/01/030801 [Registered on: 28/01/2021] Trial Registered Prospectively |
| Last Modified On: |
05/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of venous thrombosis in patients with higher risk posted for surgery |
|
Scientific Title of Study
|
Incidence of deep vein thrombosis in patients with higher risk posted for elective surgery : An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SURAVI SAMANTA |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
IMS and SUM Hospital |
| Address |
IMS and SUM Hospital
K8 Kalinganagar Ghatikia
Bhubaneswar Odisha India
Department : Anesthesiology and Critical Care. First Floor
Khordha
ORISSA
751003
India |
| Phone |
8900332282 |
| Fax |
|
| Email |
suravisamanta93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SOUMYA SAMAL |
| Designation |
PROFESSOR |
| Affiliation |
IMS and SUM Hospital |
| Address |
IMS and SUM Hospital
K8 Kalinganagar Ghatikia
Bhubaneswar Odisha India
Khordha
ORISSA
751003
India |
| Phone |
7978041867 |
| Fax |
|
| Email |
samalsoumya11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SOUMYA SAMAL |
| Designation |
PROFESSOR |
| Affiliation |
IMS and SUM Hospital |
| Address |
IMS and SUM Hospital
K8 Kalinganagar Ghatikia
Bhubaneswar Odisha India
Khordha
ORISSA
751003
India |
| Phone |
7978041867 |
| Fax |
|
| Email |
samalsoumya11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IMS and SUM Hospital |
| Address |
K8 Kalinganagar Ghatikia Bhubaneswar India
751003 |
| Type of Sponsor |
Private 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 |
| SURAVI SAMANTA |
IMS and SUM Hospital |
K8 Kalinganagar Ghatikia
Bhubaneswar Odisha India 751003
Department: Anesthesiology and Critical Care. First Floor
Khordha
ORISSA |
8900332282
suravisamanta93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INSTITUTEOF MEDICAL SCIENCES AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients satisfying the criteria of Wells Score
ASA Grade I,II,III patients |
|
| ExclusionCriteria |
| Details |
Patients of Thromboprophylaxis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DVT likely 2 point or more |
During Pre-Anesthetic Checkup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any functional limitations |
Metabolic Equivalent of Tasks more than 4 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2021 |
| Date of Study Completion (India) |
01/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/09/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My research topic is to find out the Incidence of Deep Vein Thrombosis in patients with higher risk posted for elective surgery.It is an observational study, a single blinded study Presence or absence of DVT will be observed in all the patients who meet the Well’s Score criteria. Screening by Doppler Ultrasound for both lower limbs to rule out presence or absence of DVT. |