Prospective Study to Assess the Necessity of Venous Thromboembolism Prophylaxis in

General Surgery Patients

Abin.C, Dr. T.N.K Suriyaprakash
5th year Pharm.D, Al Shifa College of Pharmacy

Abstract:
Venous thromboembolism (VTE) is a disease that includes both Deep Vein Thrombosis and
Pulmonary Embolism. Any alteration to the components of Virchows triad (venous stasis,
hypercoagulability, and endothelial damage) can result in venous thromboembolism. General
surgery is associated with a significant risk of venous thromboembolism (VTE). The high
prevalence and frequently silent onset of this condition underscore the importance of risk
assessment and appropriate prophylactic measures. 30% patients undergoing general surgery
has risk of contracting VTE. A prospective observational study was undertaken in the patients
of General Surgery department of Al Shifa Hospital Pvt Ltd with an aim of assessing the
necessity of VTE prophylaxis. The sample size for the study was determined to be 49 using
the n-Master software for sample size determination. The study involved collection of the
details of the patient and correlating their conditions to scores as assigned by Caprini Score
for VTE risk assessment, which is validated and approved by American College of Chest
Physicians in their 9th guideline. The subjects were then categorized into low, moderate and
high risk on the basis of the scores and the treatment given to each group evaluated for their
compliance to guidelines. From the total subjects evaluated, 57.14% were obese, 48.98% had
underwent major surgery with 14.29% requiring to undergo bed rest for >24 hours.
Evaluation of all the risk factors established 14.29%, 57.14% and 28.57% being categorized
in low, moderate and high risk respectively for VTE. There was a significant difference
between number of patients in the moderate and high risk as compared to low risk (p<0.05)
thus necessitating the need for adequate prophylaxis to prevent VTE.
Introduction:
Venous thromboembolism (VTE) is a major health problem with substantial morbidity and
mortality. It is often underdiagnosed due to lack of information on VTE risk and prophylaxis.
VTE occurs when alteration of one or more of the elements of Virchows triad are present

resulting in deep venous thrombosis (DVT) and/or pulmonary embolism The elements of
Virchows triad include venous stasis, hypercoagulability, and endothelial damage which are
normally under control, although a disruption of either of the 3 can cause VTE. Despite a
wealth of information regarding the mortality and morbidity associated with VTE, hospitals
worldwide continue to do poorly at preventing VTE events for at-risk patients. The risk of
developing VTE rises sharply when the number of risk factors increases. General surgery is
associated with a significant risk of venous thromboembolism (VTE). The high prevalence
and frequently silent onset of this condition underscore the importance of risk assessment and
appropriate prophylactic measures. 30% patients undergoing general surgery has risk of
contracting VTE. It is therefore quintessential to stratify the surgical patients according to the
risk of VTE and provide adequate prophylaxis as per standard guidelines. Despite a similar
proportion of at-risk hospitalized patients in India and other countries, there was major
underutilization of prophylaxis in India. It necessitates increasing awareness about VTE risk
and ensuring appropriate thromboprophylaxis
Aims & Objective:
To categorise general surgery patients on the basis of risk for VTE and assess the necessity of
VTE prophylaxis in this group
Methodology:
A prospective study was done to assess the VTE risk in General Surgery patients in a tertiary
care referral hospital in Perinthalmanna. The patients admitted as in-patients for surgical
procedures from December 2014 to January 2015 were included in the study. Sample size
calculation was estimated as 49 using n-Master software for sample size determination. The
patients were categorized into low, moderate and high risk using Caprini score for VTE risk
assessment and adequacy of VTE prophylaxis audited using NHS audit form. The data were
obtained from patient charts and direct patient and physician interview. The adequacy of
therapy was compared with the ACCP 9th AT guidelines and documented as compliant, noncompliant or partial compliance.
Results:
A total number of 49 subjects were selected on the basis of convenience sampling. Of this
57.14% (n=28) were males and 42.86% (n=21) were females. The mean age of the study
sample was determined as 53.12 (Range=24 to 77). Among the 49 patients, 32.65% (n=16),

51.02% (n=25) and 16.33% (n=8) had underwent major, minor and laparoscopic procedures
respectively. 4.08% (n=2) were underweight, 40.82% (n=20) were overweight and 16.33%
(n=8)were obese. The mean BMI was estimated as 27.32 kg/m2. 85.71% (n=42) had an
anticipated bed rest time of <24 hrs in comparison to 14.29% (n=7) who had >24 hrs. Of the
49 patients, 22.45% (n=11) had sepsis in comparison to 77.55% (n=38) who did not have
sepsis and 9 (18.37%) had malignancy in contrast with 81.63% (n=40), who did not have
malignancy. The anaesthesia used were local anaesthetic in 51.02% (n=25) as compared to
48.98% (n=24) operated with general anaesthesia. 16.33% (n=8) patients had swollen legs,
whereas 83.67% (n=41) did not have swelling. Only 4.08% (n=2) patients were on oral
contraceptive therapy. None of the patients had pregnancy or history of delivery within the
previous month. The most common comorbidities present were type 2 diabetes mellitus in
26.53% (n=13) patients and hypertension in 22.45% (n=11) patients. The risk assessment is
depicted in Figure 2 and Figure 3 represents adequacy of prophylaxis. The most common
prophylaxis given was mechanical with thigh length compression stockings in 40.82% (n=20)
patients and enoxaparin in 6.12% (n=3) patients.
Age Group

No of Patients
5
29
14
1

<40
41-60
61-74
>75

Percentage
10.2
59.18
28.57
2.04

Duration of Surgery in Patients

<45 min

0.29

45min-1hr

0.43

1-2 hr
>2

0.29

Categorization of Patients According to Caprini Score

30
25
very low

20

low
moderate

15

high

10
5
0

0
no of patients

Compliance with Guidelines

20.41 14.28

compliant
non-compliant
partial compliance

65.31

Discussion
The study demonstrated high occurrence of patients at-risk for VTE in surgical in-patients.
The proportion of patients considered at risk for VTE (57.15%) was similar to that of the

Indian patients at risk for VTE (53.6%). The ENDORSE studies has showed that there is only
17.4% patients at risk who receive adequate prophylaxis as per ACCP guidelines. The study
has showed that only 14.28% patients had received proper prophylaxis as per ACCP 9 th AT
guidelines. The most common reasons for the under-utilization was worry of excess bleeding
in the post-surgical setting. This is evident from the partial compliance with the guidelines
and utilization of mechanical prophylaxis in a fair proportion of patients in moderate and
major risk. As compare to the number of patients at high risk, the frequency of utilization of
pharmacological prophylaxis was very low. Unfamiliarity with the latest guidelines was
another factor causing inadequate VTE prophylaxis. Despite decades of evidence showing
that pharmacologic and mechanical means can help prevent VTE in hospitalized at-risk
patients, current national and international prevention strategies remain suboptimal.Omission
of VTE prophylaxis in a patient who develops a VTE is considered an adverse drug event if
pharmacologic prophylaxis was indicated or as an adverse event if mechanical prophylaxis
was indicated. Recent data revealed that in-hospital, pharmacy-driven VTE prevention
programs can increase the use of appropriate thromboprophylaxis and reduce VTE events.

Conflict of Interest:
Since there were no follow up visits, we could not evaluate the prophylaxis
duration compliance with the recommendations of the ACCP guidelines. The data
were collected from the patient charts and there was a possibility to include
inaccurate data.