| CTRI Number |
CTRI/2025/11/097740 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Clinical Profile of patients presenting with
Acute Thrombosis. |
|
Scientific Title of Study
|
An observational cross-sectional study on Clinical Profile of adult patients presenting with
Acute Thrombosis in tertiary care centre. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kandimalla Sri Kalyani |
| Designation |
Junior Resident |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
Department of General Medicine, D Y Patil Hospital, Sector 7, Nerul, Navi Mumbai
Department of General Medicine, D Y Patil Hospital, Sector 7, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8008569214 |
| Fax |
|
| Email |
kalyanikandimalla88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arundhati Barua |
| Designation |
|
| Affiliation |
D Y Patil School Of Medicine |
| Address |
Department of General Medicine, D Y Patil Hospital, Sector 7, Nerul, Navi Mumbai
Department of General Medicine, D Y Patil Hospital, Sector 7, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
|
| Fax |
|
| Email |
arundhati.barua@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kandimalla Sri Kalyani |
| Designation |
Junior Resident |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
Department of General Medicine, D Y Patil Hospital, Sector 7, Nerul, Navi Mumbai
Department of General Medicine, D Y Patil Hospital, Sector 7, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8008569214 |
| Fax |
|
| Email |
kalyanikandimalla88@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Kandimalla Sri Kalyani Department of General Medicine, D Y Patil Hospital, Sector 7, Nerul, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Kandimalla Sri Kalyani |
| Address |
General Medicine Department, D Y Patil Hospital, Sector 7,Navi Mumbai,400706 |
| Type of Sponsor |
Other [Private Deemed University] |
|
|
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 Kandimalla Sri Kalyani |
D Y Patil Hospital |
Department of General Medicine, Sector 7, Nerul, Navi Mumbai
Thane
MAHARASHTRA |
08008569214
kalyanikandimalla88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I822||Embolism and thrombosis of vena cava and other thoracic veins, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients greater than 12 years of age
Both males and females
Patients who presented to tertiary care centre with acute thrombus or proven thrombus episode.
Pregnancy |
|
| ExclusionCriteria |
| Details |
Patients below the age of 12yrs
Patient with chronic history of thrombosis.
Patients who does not give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The clinical profile and outcomes of adult patients presenting with acute thrombosis at a tertiary care center with a 90% confidence level and 8% precision. |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NIL |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
10/12/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thromboembolism includes venous thrombosis, arterial thrombosis and
pulmonary thromboembolism (PTE) a significant contributor to the worldwide
healthcare burden. The most common forms of arterial thrombosis, ischemic heart disease
(including acute myocardial infarction), and ischemic stroke. In recent years, studies have increasingly noted differences between isolated
pulmonary embolism (PE), a pulmonary thrombus diagnosed without
concomitant deep vein thrombosis (DVT), and DVT-associated pulmonary
embolism. The first difference highlighted concerned the prevalence of the Factor V
Leiden mutation (F5 G1691A), a missense substitution that renders activated
coagulation factor V resistant to inactivation by activated protein C,
facilitating excessive thrombin generation. A second notable finding was that cardiac disease appears to be more
prevalent among patients with isolated PE than among patients with DVT
associated PE.3,4 Large cross-sectional studies have provided evidence that
atrial fibrillation, coronary artery disease, history of myocardial infarction and
stroke, and cardiomyopathy and (left-sided) heart failure are overrepresented
in patients with isolated PE. There is a need, therefore, to investigate and define the clinical profile of
patients with thrombosis among this population, in order to recognize those
who will need considerate attention to prevent complications like pulmonary
embolism. The main reason for the increased risk of thromboembolism in pregnancy is
hypercoagulability, which has likely evolved to protect women from the
bleeding challenges of miscarriage and childbirth. Women are at a 4- to 5-fold
increased risk of thromboembolism during pregnancy and the postpartum
period compared with when they are not pregnant. Antiphospholipid antibodies (APLAs) are autoantibodies that target
phospholipid-binding proteins, the hallmark of APS comprises the
persistent presence of APLAs in the setting of arterial and venous thrombus or
pregnancy loss, the most common sites for venous and arterial thrombosis are
the lower limbs and cerebral arterial circulation, respectively. However,
thrombosis can occur in any organ. APLAs include: Anticardiolipin antibodies IgG or IgM (ELISA), Anti-beta-2
glycoprotein-I (anti-beta2GPI) antibodies IgG or IgM (ELISA), Lupus anticoagulants
(functional clotting assays). Combined oral contraceptives combine with a heterozygous factor V Leiden
mutation, the risk of venous thrombosis is increased up to 35-fold, while 16
fold if combined with prothrombin G20210A mutation. Study site: Department of General Medicine, Dr DY Patil Hospital
Study population: Patients attending OPD and IPD of Department of Medicine. Inclusion Criteria 1. Adult patients (>12yrs)
2. Both males and females
3. Patients who presented to tertiary care centre with acute thrombus or
proven thrombus episode.
4. Pregnancy Exclusion criteria1. Patients below the age of 12yrs
2. Patient with chronic history of thrombosis.
3. Patients who does not give consent. |