Anda di halaman 1dari 17

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION &

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

Assessing risk factors for the development of Venous


Thromboembolism (VTE) in surgical patients using
Adapted Caprini Scoring System

2. Name, Designation & Address of the

Principal Investigator with mobile number,

Dr. Vikram Kate


Professor

e-mail ID & number of ongoing projects as

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. Pankaj Kundra


Professor and Head
Department of Anaesthesiology
JIPMER
Mobile No: 9361602030
E-mail ID: p_kundra@hotmail.com
Dr. Suresh Kumar S
Assistant Professor
Department of Surgery
JIPMER
Mobile No: 9788637893
E-mail ID: drsureshkumar08@yahoo.com

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

5. A. If the study is institutional, state

Inter-departmental

whether it is
Intra-departmental or inter-departmental.
B. If the study is inter-departmental,
(i)

State the names of

:
:

Department of Surgery

collaborating departments

Department of Anaesthesiology
Department of PSM

(ii)

State whether consent has

Yes

NA

NA

been obtained from them


6. A.If the study is inter-institutional, state
whether it is national or international.
B.State the name of coordinating
institution
C.State the names of collaborating
institutions.
D.State whether consent has been
obtained from collaborating
institutions. Enclose copies of the
same.
E. State whether you have enclosed a
copy of the original research protocol
submitted by the coordinating
institution.
F. State the responsibilities of each
collaborating institution.
7. Total funds required for the study (in
rupees)
8. A. Source of funding (intramural or
extramural)
B. If extramural, state the name of
funding agency
PART B TECHNICAL DETAILS

1. Title of the project

Assessing risk factors for the development of Venous


Thromboembolism (VTE) in surgical patients using Adapted
Caprini Scoring System

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

Data on the incidence of VTE in Indian population is sparse


and no such study on the incidence and risk stratification
has been done so far in our institute

C. Expected outcome & application

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

4. Research hypothesis(es), if any

Adapted Caprini Scoring is valid and reliable in risk


stratification for VTE prophylaxis in surgical patients

5. Aim and objectives: Primary objective(s)&secondary objective(s):


Primary objectives
1. To determine the incidence of VTE in surgical patients
2. To assess the validity and reliability of Adapted Caprini Scoring in risk stratification for VTE
prophylaxis
Secondary objectives
1. To estimate the morbidity and mortality related to VTE
2. To identify the independent patient risk factors for developing VTE
3. To assess the complications of VTE prophylaxis

6. Brief review of literature:


Incidence of VTE in Indian population estimated to range from 6% to 28% in various literatures
however real incidence might be even higher due to the gross underreporting and inadequate
documentation.[1-4] Pulmonary embolism is one of the commonest cause of sudden unexplained death
in the hospitalized patients and as high as 10% of inpatient deaths are attributed to PE. [2-4] Though it
was considered that Indian population is less prone for development of VTE, in the recent studies it
has been shown that incidence of DVT is comparable to the western population and Indian patients do
have the high risk factors for the development of VTE.
Pinjala etal in the ENDORSE multinational cross sectional study shown that 53.9% of surgical
patients in Indian subset has high risk for development of VTE. [1] An autopsy study on 1000 medical
patients at the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
revealed that PE was present in 159 (16%) of 1000 patients who died in the hospitalit was a fatal
embolus in 36 and was a major contributor to death in 90 patients; clinical (pre-mortem) suspicion of
PE was recorded in 30% of patients and a diagnosis of PE could be made in <10%. [2]
Fear of complications including major bleeding, heparin induced thrombocytopenia etc and
lack of comprehensive and cost effective risk assessment tool are shown as the reasons for nonadherence in the DVT prophylaxis in many Indian studies. [3, 4] Various assessment methods have been
tried in the literature to accurately stratify the patients in to risk group for VTE prophylaxis including
revised Caprini Risk assessment scoring, Geneva guidelines, ACCP guideline etc. [5,6,7]
Caprini scoring is one of the widely used a validated risk assessment model, however requires
some laboratory investigation which are not widely available which limits its use in the developing
countries.[8,9] Hence to make it practicable in the developing countries like India where expenditure of
health care delivery system have to be prioritized, a adapted Caprini risk assessment scoring system
excluding some of the investigations needs to be validated.

7. Study participants

Humans

(humans, animals or both)

8. Study design / type

Prospective observational study

9. For participants, mention

All patients admitted in Department of Surgery for Elective

A.

Inclusion criteria

and Emergency surgical procedures under GA/RA from


March 2014- Nov 2014 (9 months)
B.

Exclusion criteria

1.
2.
3.
4.

Patients diagnosed to have VTE at admission


Previously treated for DVT/ PE
Patient on anticoagulation therapy for any reason
Patients planned for lower limb vascular

interventions/ vascular surgery


5. Patients with clear indication for therapeutic
anticoagulation
6. Patients in whom anticoagulants are
contraindicated ( bleeding disorder,
thrombocytopenia)

10. Number of groups to be studied, their

One

All patients admitted in department of general surgery for

names and definitions


11. Sampling

elective and emergency surgical procedures carried out


A. Population

under general of regional anaesthesia.

B. Sampling method

C. Sample size in each group and

All Patients admitted from March 2014 to November 2015

NA

A. Selection of participants

B. Allocation to groups

sample size calculation method


12. Randomization details

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

Age 41-60 years

Age 60-70 years

Minor surgery planned (< 45 min)

Malignancy (present or previous)

H/o prior major surgery (<1 month)

Major surgery (>45 minutes)

Varicose veins

Laparoscopic surgery (>45 minutes)

H/o inflammatory bowel disease

Patient confined to bed (>72 hours)

Swollen legs (current)

Immobilising plaster cast (<1 month)

Obesity (BMI>25 kg/m2)

Central venous access

Acute myocardial infarction

Congestive cardiac failure (<1 month)

Sepsis (<1 month)

Serious lung disease, pneumonia (<1


month)

Abnormal pulmonary function (COPD)

3 points each

5 points each

Age >75 years

H/O DVT/PE

Family h/o thrombosis

Hip /pelvis / leg fracture (<1 month)

Heparin induced thrombocytopenia

Stroke (<1 month)

(HIT)

H/o multiple trauma (<1 month)

Congenital or acquired thrombophilia

Acute spinal cord injury (paralysis)

Elective major lower extremity


arthroplasty

(<1m)
For women only, 1 point each

Risk

scoring

grouped

categories
OCPs or HRT
Low risk

: 0-1

Pregnancy or postpartum <1 month


H/o
recurrent

unexplained
spontaneous

stillborn
abortions

Moderate risk : 2

infant,
>=

High risk

3,
7

: 3-4

in

to

four

premature birth with toxaemia or growth

Very high risk : > 5

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]

Swelling of the leg or along a vein in the leg

Pain or tenderness in the leg, which you may feel only when standing or walking

Increased warmth in the area of the leg that's swollen or painful

Red or discoloured skin on the leg

Pulmonary Edema symptoms/signs [4-6]

Unexplained shortness of breath

Pain with deep breathing

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.

PE diagnosis is confirmed by Spiral CT scan of the chest, or echocardiography in major PE and


hemodynamic instability. Treatment for proven/ established DVT and PE will be done as per the
existing protocol.
To assess the validity and reliability of Adapted Caprini Scoring
The risk group and the incidence of VTE in the category will be estimated. Availability of all the
information/ variables in each patient required for the scoring and risk stratification is also
documented. Rationalization/ validation of risk group or scoring will be done if required.
Morbidity of DVT will be assessed by the following complications

[1, 4-6]

Phlegmasia Alba Dolens (fulminant venous thrombosis without ischemia)


Phlegmasia Cerulea Dolens- requiring endovascular intervention/ surgical thrombectomy
Morbidity in terms of ischemia/ gangrene of the leg
Major/ minor amputations
Fasciotomy for compartment syndrome

Morbidity of PE will be assessed by [1,4-6]

Requirement of assisted mechanical ventilation


Length of hospital stay due to VTE

Mortality due to VTE [1, 2, 4-6]


Death is considered to be a result of VTE if the patient is diagnosed as VTE, VTE diagnosis is
confirmed by the aforementioned investigations and there are no other possible clinical
explanations for death
Complications of VTE prophylaxis will be assessed by [1, 2, 4-6]

Incidence of minor bleeding- do not require transfusion :


o
Injection site bruising
o
Wound hematoma
o
Drain site bleeding
o Hematuria
Major bleeding- requiring transfusion:
o GI bleeding
o Retroperitoneal bleeding
o Requiring subsequent operation/ surgical procedure for control of bleeding
Heparin induced thrombocytopenia

14. Are the drugs/devices to be used

NA

approved for these indications by Drug


Controller General of India (DCG-I)?
15. Statistical analysis: List of variables and

their measurement methods with

standardization techniques
A. Independent variables

Caprini score, Surgery performed, Diagnosis at


admission, Receipt of prophylaxis for DVT, H/o DVT/ PE,
Major pelvic/ poly trauma

B. Dependent variables

Development of Deep Vein Thrombosis

C. Confounding & interacting variables

Surgery performed, Diagnosis at admission, Receipt of


prophylaxis for DVT will be the confounding factors while
assessing the risk factors for DVT, they will adjusted
using stratified analysis or multivariate logistic
regression

16. Data collection methods including settings & periodicity:


After obtaining written informed consent, data and variables according to the Adapted Caprini scoring
system will be recorded by the principle investigator or the co- investigators in all the patients included
in the study in a specified Proforma at admission.
The Proforma will include the patients baseline characteristics such as age, gender, BMI and
telephone number (two numbers- to decrease lost to follow up). Diagnosis at admission, surgery
planned/ performed and will be collected.
At the time of discharge the Caprini score will be updated by the treating surgeon/ anaesthetist with
any added risk factor variable. The Caprini score will be scored by two persons independently for
assessing the inter-rater reliability. The symptoms/ signs of DVT & PE will be evaluated at 3 rd, 7th, 14th
and 30th day in patients who remains in the in-patient care.
Patients who gets discharged before 30 days, the symptoms of DVT is assessed on the above
specified days either personal or telephonic interview and during discharge they will be advised to
report to OPD/ EMSD if they develop any such symptoms.
Measures taken to decrease lost to follow-up: two telephone numbers will be collected for
contacting the subjects, at the time of recruitment subjects / along with the informed consent the
phone number of the researcher will be given to the subjects so and will be asked to report to the
researcher if any of they have any symptoms of DVT
17. List variable-wise statistical tests to be used for data analysis
For missing values of the symptoms of VTE the last observation will be carried forward
Incidence of VTE will be summarized as proportion.
Receiver Operating Curve (ROC) will be plotted for the Caprini score to identify cut off
point for predicting VTE using the Caprini score.

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

Investigation for diagnosing DVT and CT Angiogram for PE


Inter- rater reliability of the Caprini score will be assessed using kappa statistics.
The outcome of the patients with VTE will be summarized as proportions
The risk factors for developing VTE will be assessed using relative risk and 95% CI.
Stratified analysis or logistic regression will be used to adjust for the confounding effect

18. List risks and benefits of the study to the Participants:


Risk:
Less than minimal risk (according to ICMR 2006 guideline)
Study involves only data collection from the patient records
No intervention is done other than the treatment and intervention planned by the treating
surgeon as per the existing protocol
Benefits:
If the study proves the validity of the adapted Caprini score for the risk stratification and
risk group likely to develop DVT, prophylaxis can be given to the targeted group

19. Relevant references for the project


(Maximum 20) (in Vancouver style, to be cited sequentially in the text of project):
1. Ramakrishna

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,

Babu R, S Postoperative Venous

Thromboembolism Prophylaxis by General Surgeons in a Developing Country: A Survey


Thrombosis. 2013; 2013: 873750. PMCID: PMC3818923 doi: 10.1155/2013/873750
5. Narani KK. Deep vein thrombosis and pulmonary embolism Prevention, management, and
anaesthetic considerations. Indian J Anaesth 2010;54:8-17
6. Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, et al.; American
College of Chest Physicians. Prevention of venous Thromboembolism: American College of
Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008;133
(6 Suppl):381S453S
7. Cohen AT, Tapson VF, Bergmann JF, Goldhaber SZ, Kakkar AK, Deslandes B, et al.;
ENDORSE Investigators. Venous Thromboembolism risk and prophylaxis in the acute
hospital care setting (ENDORSE study): A multinational cross-sectional study. Lancet 2008;
371: 38794. Erratum in: Lancet 2008; 371: 1914.
8. Caprini JA. Thrombosis risk assessment as a guide to quality patient care. Dis Mon. 2005; 51:
7078.
9. Pannucci C J, Bailey S H, Dreszer G etal. Validation of the Caprini Risk Assessment Model in
Plastic and Reconstructive Surgery Patients J Am Coll Surg. 2011 January; 212(1): 105112.

20. Enclosures

A. For Part A No. 6

NA

B. For Part B No.14

NA

C. Data collection Proforma

Enclosed

D. Questionnaires

NA

E. Others

12

Signature of the Investigator

Signature of Head of the Department


of the Investigator

Dr. Vikram Kate

Dr. K. Srinivasan

Professor

Professor & Head


Department of surgery

Department of Surgery

Signature(s) of the Co-Investigator(s)

Signature(s) of Head(s) of the Department


of the Co-Investigator(s)

Dr. Pankaj Kundra

Dr. Pankaj Kundra


Professor and Head
Department of Anaesthesiology
JIPMER

Professor and Head


Department of Anaesthesiology
JIPMER

Signature(s) of Head(s) of the Department

Signature(s) of the Co-Investigator(s)

of the Co-Investigator(s)

Dr. Suresh Kumar S

Dr. K. Srinivasan

Assistant Professor

Professor & Head

Department of Surgery

Department of surgery

JIPMER

Signature(s) of the Co-Investigator(s)

Signature(s) of Head(s) of the Department

Dr. Mahalakshmy T

of the Co-Investigator(s)

Assistant professor

Dr. Gautam Roy

Department of PSM

Prof& Head
Department of PSM

Signature(s) of Head(s) of the Department

Signature(s) of the Co-Investigator(s)

of the Co-Investigator(s)

Dr. Kanchan Bilgi

Dr. Pankaj Kundra


Professor and Head
Department of Anaesthesiology

Junior Resident

13

Department of Anaesthesiology

JIPMER

Signature(s) of Head(s) of the Department

Signature(s) of the Co-Investigator(s)

of the Co-Investigator(s)

Dr. Arun Kumar

Dr. K. Srinivasan

Junior Resident

Professor & Head

Department of surgery

Department of surgery

Data Collection Proforma

Case S.no:

Name:

Age:

Gender:
M/ F

IP NO:
Date of admission:

Phone No1:

Date of discharge:

Phone No2:

BMI

Diagnosis at admission:

Operative procedure planned:

Diagnosis at discharge:

Operative procedure performed

ADAPTED CAPRINI SCORING METHOD

14

Elective/
Emergenc
y

1 point each:

2 points each

Age 41-60 years

Age 60-70 years

Minor surgery planned (< 45 min)

Malignancy (present or previous)

H/o prior major surgery (<1 month)

Major surgery (>45 minutes)

Varicose veins

Laparoscopic surgery (>45 minutes)

H/o inflammatory bowel disease

Patient confined to bed (>72 hours)

Swollen legs (current)

Immobilising plaster cast (<1 month)

Obesity (BMI>25 kg/m2)

Central venous access

Acute myocardial infarction

Congestive cardiac failure (<1 month)

Sepsis (<1 month)

Serious lung disease, pneumonia (<1


m)

Abnormal pulmonary function


(COPD)

TOTAL SCORE:----------------------

TOTAL SCORE:---------------------3 points each

5 points each

Age >75 years

Elective major lower extremity


arthroplasty

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

Acute spinal cord injury (paralysis) (<1m)

TOTAL SCORE:----------------------

TOTAL SCORE:----------------------

15

For women only, 1 point each


OCPs or HRT
Pregnancy or postpartum <1 month
H/o unexplained stillborn infant, recurrent spontaneous abortions >= 3, premature birth
with toxaemia or growth restricted infant
TOTAL SCORE:---------------------RISK SCORING GROUPED IN TO FOUR CATEGORIES
AT ADMISSION

AFTER 72 HOURS/ AT DISCHARGE


(whichever is earlier)

Low risk

Low risk

: 0-1

: 0-1

Moderate risk : 2

Moderate risk : 2

High risk

High risk

: 3-4

Very high risk : > 5

: 3-4

Very high risk : > 5

VTE PROFILE
VTE detected at

3rd/ 7th/14th/30th day

As inpatient/ after discharge

DVT prophylaxis

Received/ not received

Drug formulation/ dosage/ route

VTE confirmed by

Duplex USG (DVT)

CT Angiogram (PE)

Complications of VTE

Complications due to DVT

Complications due to PE

16

Complications due to

Minor

Major

HIT

DVT Prophylaxis

Mortality

Inpatient/ after discharge

Day after surgery

Attributed to VTE

YES/ NO ( state reason)

ICU/ HDU/ WARD

Sudden Death YES/ NO


OTHER DETAILS

17