| CTRI Number |
CTRI/2019/07/020110 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
08/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Percentage rate and causative factors leading to Clot formation in deep veins of leg in patients undergoing operation for large abnormal growth in brain - a study proposed ahead in time. |
|
Scientific Title of Study
|
Incidence and risk factors of Deep Vein Thrombosis in patients undergoing large supratentorial tumor surgery- a prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arohan Gupta |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Neuroanaesthesia and Critical Care
CN Centre
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9465440072 |
| Fax |
|
| Email |
arohangupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navdeep Sokhal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Neuroanesthesia and Critical Care
7th Floor, CN Centre
AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9953279619 |
| Fax |
|
| Email |
drnavdeepsokhal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arohan Gupta |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Neuroanaesthesia and Critical Care
CN Centre
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9465440072 |
| Fax |
|
| Email |
arohangupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Navdeep Sokhal |
Associate Professor
Department of Neuroanesthesia and Critical Care
7th Floor
CN Centre
AIIMS, New Delhi-110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arohan Gupta |
AIIMS |
Department of Neuroanesthesia, 7th Floor,
CN Centre
New Delhi
DELHI |
9465440072
arohangupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D330||Benign neoplasm of brain, supratentorial, (2) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients aged 18-65 years.
2) Supratentorial tumor size greater than 4 cm in size in any dimension or greater than 20 ml in volume, either of the above. |
|
| ExclusionCriteria |
| Details |
1) Patient refusal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of DVT (Deep Vein Thrombosis) in patients undergoing large supratentorial tumour surgery. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Risk factors related to the occurrence of Deep Vein Thrombosis in these patients.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
16/07/2019 |
| 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="6"
Days="0" |
|
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 observational study. Our aim is to determine the incidence and risk factors of Deep Vein Thrombosis in patients undergoing large supratentorial tumor surgery. Deep vein thrombosis will be diagnosed by ultrasonographic assessment of bilateral lower limbs pre-operatively, on post-op day 2, day 5, day 7 and subsequently every week until discharge of the pateint. Pre-operative, intra-operative and post-operative data will be collected to determine the factors related to the occurence of Deep Vein Thrombosis. |