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RESEARCH, PUDUCHERRY-605006
(Institute of National Importance under Govt. of India)
FORMAT
FOR SUBMITTING RESEARCH PROJECT FOR CONSIDERATION BY JIPMER SCIENTIFIC
ADVISORY COMMITTEE (JSAC)
PART A GENERAL INFORMATION
1. Title of the Project
Department of Surgery
Principal Investigator
JIPMER
Mobile No: 9843058013
E-mail ID: drvikramkate@gmail.com
No of ongoing projects: One
3. Name(s), Designation(s) & Address(es) of
the Co-Investigator(s) with mobile
numbers & e-mail IDs
Dr. Mahalakshmy T
Assistant Professor
Department of PSM
JIPMER
Mobile No: 9488729774
E-mail ID:mahalaksmi.dr@gmail.com
Dr. Kanchan Bilgi
Junior Resident
Department of Anaesthesiology
JIPMER
Mobile No: 8526617221
E-mail ID: kanchanbilgi@gmail.com
Dr. Arun Kumar
Junior Resident
Department of surgery
JIPMER
Mobile No: 9486199719
E-mail ID: arunjipmer2006@gmail.com
4. Duration of study
9 months
Inter-departmental
whether it is
Intra-departmental or inter-departmental.
B. If the study is inter-departmental,
(i)
:
:
Department of Surgery
collaborating departments
Department of Anaesthesiology
Department of PSM
(ii)
Yes
NA
NA
2. Background:
Venous Thromboembolism (VTE) is a significant cause of morbidity in surgical patients and one of
the important preventable causes of in-patients mortality. VTE is a spectrum of disease that
includes Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE). There is a common
presumption that VTE is not so frequent in Asian population particularly Indian subgroup, however
recent Indian studies have shown that VTE in our population is not a rare occurrence as it was
thought before.[1,2] Lack of proper risk factor assessment tool, inadequate documentation,
asymptomatic presentations of VTE, misdiagnosed or attributed to other diagnosis and inadequate
follow up in postoperative period are the few obstacles in quantifying the actual burden of VTE and
magnitude of its complications.[3,4] Addressing the above issues and assessing the risk factors with
the practicable and easy to use method/ Tool is required to set up guidelines/ recommendations on
VTE prophylaxis.
A. Rationale:
Correctly identifying the risk group for VTE prophylaxis is very important to reduce the incidence of
VTE and related morbidity and mortality. Routine VTE prophylaxis increases the risk of bleeding
and other complications in addition to unnecessary cost burden to the health care delivery system.
The existing methods for risk group classification based on the Western studies are cumbersome
and involves expensive investigations which limits the wide acceptance of its usage. Hence it is
paramount importance to device a comprehensive risk assessment tool and validates the same.
B. Novelty
Incidence of VTE
Validity of Adapted Caprini Scoring in identifying the risk
groups for VTE prophylaxis
3. Research question(s)
1. What is the incidence of VTE (DVT& PE) in surgical patients?
2. Is Adapted Caprini score valid and reliable tool for the risk stratification of Indian population for VTE
prophylaxis
7. Study participants
Humans
A.
Inclusion criteria
Exclusion criteria
1.
2.
3.
4.
One
B. Sampling method
NA
A. Selection of participants
B. Allocation to groups
13. Methods: Intervention details with standardization techniques(drugs / devices / invasive procedures /
non-invasive procedures / others):
Informed written consent is obtained from all the patients recruited for the study. Strict protocol for
mobilization of the patients as early as possible following surgery will be observed unless
contraindicated; those who cannot be mobilized will receive passive exercises. The baseline data
and the risk factor assessment will be done according to the adapted Caprini Scoring.
1 point each:
2 points each
Varicose veins
3 points each
5 points each
H/O DVT/PE
(HIT)
(<1m)
For women only, 1 point each
Risk
scoring
grouped
categories
OCPs or HRT
Low risk
: 0-1
unexplained
spontaneous
stillborn
abortions
Moderate risk : 2
infant,
>=
High risk
3,
7
: 3-4
in
to
four
restricted infant
The decision to start VTE prophylaxis for each patient will be left to the treating consultant of the unit.
No alteration/ suggestion in the treatment plan or the post-operative intervention will be done for the
study.
Primary and secondary outcome measures will be assessed as follows
To estimate the incidence, all patients included in the study will be assessed clinically for symptoms
and signs of VTE in the postoperative period which include the following
DVT Symptoms/ signs [4, 5]
Pain or tenderness in the leg, which you may feel only when standing or walking
Coughing up blood
Patients in whom VTE is suspected, further investigations are done to confirm the diagnosis. Duplex
Ultrasound assessment of bilateral common femoral, superficial femoral, popliteal, anterior tibial and
posterior tibial veins is done for DVT. They are assessed for flow, visualized thrombus, compressibility
and augmentation.
A diagnosis of DVT will be made where there is visualization of thrombosis, absence of flow, lack of
compressibility or lack of augmentation. To assess the further propagation of the thrombus, a repeat
Duplex study will be done in all these patents within a week of the first positive Doppler study.
[1, 4-6]
NA
standardization techniques
A. Independent variables
B. Dependent variables
10
After obtaining the cut off value using ROC the sensitivity and specificity of the Caprini
score will be calculated using the Duplex Ultrasound assessment as the Gold Standard
Pinjala,
on
behalf
of
all
ENDORSE-India
investigators
venous
Thromboembolism risk & prophylaxis in the acute hospital care setting (ENDORSE), a
multinational cross-sectional study: Results from the Indian subset data Indian J Med Res.
2012 July; 136(1): 6067.
2. Kakkar N, Vasishta RK. Pulmonary embolism in medical patients: An autopsy-based study.
Clin Appl Thromb Hemost 2008; 14: 15967.
3. Todi SK, Sinha S, Chakraborty A, Sarkar A, Gupta S, Das T, et al. Utilisation of deep venous
thrombosis prophylaxis in medical/surgical intensive care units. Indian J Crit Care Med 2003;
7: 1035.
11
4. Venkataram A, Santhosh S,
Dinakar D, Siddappa S,
20. Enclosures
NA
NA
Enclosed
D. Questionnaires
NA
E. Others
12
Dr. K. Srinivasan
Professor
Department of Surgery
of the Co-Investigator(s)
Dr. K. Srinivasan
Assistant Professor
Department of Surgery
Department of surgery
JIPMER
Dr. Mahalakshmy T
of the Co-Investigator(s)
Assistant professor
Department of PSM
Prof& Head
Department of PSM
of the Co-Investigator(s)
Junior Resident
13
Department of Anaesthesiology
JIPMER
of the Co-Investigator(s)
Dr. K. Srinivasan
Junior Resident
Department of surgery
Department of surgery
Case S.no:
Name:
Age:
Gender:
M/ F
IP NO:
Date of admission:
Phone No1:
Date of discharge:
Phone No2:
BMI
Diagnosis at admission:
Diagnosis at discharge:
14
Elective/
Emergenc
y
1 point each:
2 points each
Varicose veins
TOTAL SCORE:----------------------
5 points each
H/O DVT/PE
Hip /pelvis / leg fracture (<1 month)
Family h/o thrombosis
Stroke (<1 month)
Heparin induced thrombocytopenia
H/o multiple trauma (<1 month)
(HIT)
Congenital or acquired thrombophilia
TOTAL SCORE:----------------------
TOTAL SCORE:----------------------
15
Low risk
Low risk
: 0-1
: 0-1
Moderate risk : 2
Moderate risk : 2
High risk
High risk
: 3-4
: 3-4
VTE PROFILE
VTE detected at
DVT prophylaxis
VTE confirmed by
CT Angiogram (PE)
Complications of VTE
Complications due to PE
16
Complications due to
Minor
Major
HIT
DVT Prophylaxis
Mortality
Attributed to VTE
17