24 © JAPI • februAry 2013 • VOL. 61
Abstract
Objectives: To monitor the different antithrombotic drug combinations, determine the incidence, magnitude of
bleeding and the association of HAS-bLeD risk scoring schema with the magnitude of bleeding as defined using
TIMI bleeding criteria.
Methods: A prospective observational study in a cohort of patients for a period of 8 months, at one of the tertiary
care center-Krishna Institute of Medical Sciences, Hyderabad, was conducted. Consecutive patients were enrolled
and followed from the date of admission till the adverse events are perceived/date of discharge. Pearson Correlation
Statistics (fisher’s z Transformation) is applied to assess the association between HAS-bLeD risk factors and the
total risk score with bleeding criteria.
Results: A total of 400 cases were collected during the 8-month study period, of which 372 satisfied the inclusion
criteria. Among them 34 (9.1%) bleeding cases were reported with mean (± SD) age of 57.8 (±14.19) years. bleeding
occurred mostly in males 79.4% and a HAS-BLED Score of ≥3 has been observed in 67.6% (n=23) patients out of
34 bled patients. Two antiplatelets + One anticoagulant is the most common combination which caused bleeding
in 41. 2% (n=14). Stroke history, bleeding predisposition, labile INR’s are the HAS-BLED risk factors which are
significant (<0.05) with the TIMI bleeding Criteria.
Conclusion: There was a linear correlation between the HAS-bLeD risk score and the TIMI bleeding criteria-higher
the risk score the more frequent is the incidence of major bleeding. A HAS-BLED risk score of ≥3 is associated
with TIMI major bleeding.
*
M Pharmacy, Department of Hospital and Clinical Pharmacy, bharat
Institute of Pharmacy, Hyderabad 501510, Andhra Pradesh;
#
Krishna
Institute of Medical Sciences, Hyderabad;
**
Consultant Cardiologist,
Krishna Institute of Medical Sciences, Hyderabad 500003, Andhra
Pradesh;
***
Assistant Professor, Department of Pharm D, bharat
Institute of Pharmacy, Hyderabad 501 510, Andhra Pradesh
received: 19.09.2011; Accepted: 08.11.2011
Introduction
D
ue to a large increase in the number of patients with
thrombotic diseases- atrial fbrillation, prosthetic heart
valves, cardioembolic ischemic cerebral disease, myocardial
infarction, pulmonary thromboembolism and venous
thromboembolism worldwide in the recent years, antithrombotic
therapy is often chosen to treat such high vascular risk patients.
1
Though the antithrombotic combination treatments has improved
the vascular diseases in patients, the risk of bleeding remains
a signifcant issue.
2
The risk of bleeding has been evaluated in
many clinical trials using various schemas like CHADS
2
score (1
point for Congestive heart failure, Hypertension, Age 75 years
and older, and Diabetes, and 2 points for previous Stroke),
CHA
2
DS
2
-VASc score (Congestive heart failure, Hypertension,
Age ≥75 years, Diabetes mellitus, Stroke, Vascular disease, Age
65 to 74 years, Sex category),
3
HeMOrr
2
HAGeS score (Hepatic
Or renal Disease, ethanol Abuse, Malignancy, Old Age (Older
Than 75 years), reduced Platelet Counts Or Platelet Dysfunction,
uncontrolled Hypertension, Anemia, Genetic factors, elevated
fall risk, Stroke, And 2 Points for re-bleeding).
4
The new
bleeding risk score HAS-bLeD (Hypertension, Abnormal
renal/liver function, Stroke history, bleeding history, Labile
International Normalized Ratio, Elderly, Drugs/alcohol
concomitantly; 1point for each risk factor, maximum of 9
points altogether) has recently been proposed as a practical
tool to assess the individual bleeding risk of real world Atrial
fibrillation patients.
5
Patients with diferent risk factors receiving
antithrombotic therapy are prone to bleeding, which has been
proved in many clinical studies. There is a need to determine the
association of various risk factors with the bleeding outcome,
which can be defned using standard bleeding defnition like
TIMI (Thrombolysis In Myocardial Infarction), GuSTO (Global
utilisation of Streptokinase and Tissue Plasminogen Activator
for Occluded Coronary Arteries)
6,7
e.t.c. The American College
of Cardiology task force on clinical standards recommends that
the TIMI classifcation be used as the standard.
8
The aim of this
study is to monitor the incidence, magnitude of bleeding and
determine the association of HAS-bLeD risk scoring schema
with the magnitude of bleeding as defned using TIMI bleeding
criteria.
Materials and Methods
A prospective observational study in a cohort of patients
for a period of 8 months, from December 2010 to July 2011 at
a tertiary care center-Krishna Institute of Medical Sciences,
Hyderabad, was conducted. Consecutive patients were enrolled
and followed from the date of admission till the adverse events
are perceived/date of discharge. Study objectives are (i) To
monitor the diferent antithrombotic drug combinations in
a prescription (ii) To observe the incidence of bleeding after
antithrombotic therapy (iii) To apply HAS-bLeD risk scoring
schema in the patients experienced with bleeding (iv) To assess
the magnitude of bleeding using TIMI bleeding criteria and (v)
To determine the association between HAS-bLeD risk score
and TIMI criteria. All the patients who were prescribed with
at least one antithrombotic drug, aged above 18 years and had
a hospital stay of at least 24 hours were included in the study.
Patients admited to other than cardiology department were not
included. Study is conducted for prescriptions that are ordered
by physicians and medications administered to patients during
the in-hospital stay. Data were procured using a case report form
Original Article
Study on Incidence of Bleeding in Hospitalized Patients
after Antithrombotic Therapy at a Tertiary Care Hospital
K Prudhvi
*
, V Daya Sagar Rao
#
, RK Jain
#
, PA Jiwani
#
, TNC Padmanabhan
#
, G Ravikanth
#
,
VS Srinath
**
, NVR Praveen Kumar Tavva
***
110 © JAPI • februAry 2013 • VOL. 61