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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECT OF DISSERTATION
NAME OF CANDIDATE
:
SIMI ELEZEBETH PAUL
ADDRESS
:
SIMI ELEZEBETH PAUL
MSC MLT HAEMATOLOGY AND
TRANSFUSION MEDICINE
DEPT. OF CLINICAL PATHOLOGY,
ST.
JOHN’S
MEDICAL
COLLEGE
HOSPITAL,
BANGALORE-560 034
NAME OF INSTITUTION
:
ST.
JOHN’S
MEDICAL
HOSPITAL,
BANGALORE-560 034
COURSE
OF
STUDY
COLLEGE
MSC. MLT (HAEMATOLOGY
TRANSFUSION MEDICINE)
AND :
SUBJECT
AND
04.08.2008
DATE OF ADMISSION TO THE :
COURSE
TITLE OF THE DISSERTATION
AN ANALYSIS OF INDICATIONS AND
PATTERNS OF USAGE OF FFP IN ICU
SETTING
:
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1.NEED FOR STUDY:
Fresh Frozen plasma (FFP) is a blood product used by different clinical
specialities in Hospital practice. Plasma transfusion is done either therapeutically or
prophylatically when there are abnormal coagulation screening tests .
(1)
However
inappropriate usage not only leads to unwanted wastage but also leads to risk of various
transfusion associated complications. Plasma is used for various conditions in patients
admitted in Intensive Care Unit (ICU). The study aims at assessing the indications and
pattern of usage of FFP in ICU setting.
2.REVIEW OF LITERATURE
2.1. INTRODUCTION
Fresh Frozen Plasma / Human donor plasma is obtained from a
single blood donation or plasmapheresis and is prepared by freezing plasma to a
temperature of -300C or less within 6hrs of collection, to preserve the activity of
coagulation factor .(2)Each unit contains near- normal levels of most coagulation
factors, acute phase proteins, Immunoglobulin and albumin. Usually volume between
180 and 300ml is collected
(1).
By definition each ml of idealized plasma contains 1
International Unit (IU) of each coagulation factor. Therefore 1 unit FFP contains 200
IU of each coagulation factors.(3) Single unit of FFP also contains approximately
400mg fibrinogen and 1 unit/ml of factor V & VIII . (4)
Shelf life of FFP at -300C is 1 year. When frozen at -650C it may be stored up to 7
years. FFP is thawed in a 370C water bath (20-30 minute) upon request and can be
stored after thawing for up to 5 days at 1-60C.
Factor VIII level in the FFP is used as quality control of the product, this level must be
met for a proportion of units (approximately 75%)
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2.2 INDICATIONS FOR FFP
The guidelines published by College of American Pathologists (CAP) were used as
standard and include:
1. History or clinical course suggestive of a coagulopathy due to a congenital or
acquired deficiency of coagulation factors, with active bleeding or other
invasive procedures. This must be documented by at least one of the following
a) PT greater than 1.5 times the mid point of normal range.
b) APTT greater than 1.5 times the top of normal range
c) Coagulation assay of less than 25% activity.
2. Massive blood transfusion:
Replacement of more than 1 blood volume with in several hours with evidence
of coagulation deficiency as in (2.2.1) with continued bleeding.
3. Reversal of warfarin effect:
If immediate haemostasis is required to stop active bleeding or prior to
emergency surgery or an invasive procedure (PT>18 Second or INR >1.6)
4. Prophylatically for surgery or invasive procedure is cases of documented
congenital or acquired coagulation factor deficiency
5. Deficiency of antithrombin, heparin cofactor II, protein C or protein S.
6. Plasma exchange for thrombotic thrombocytopenic purpura or haemolytic
uraemic syndrome(5)
2.3 DOSE AND ADMINISTRATION
The dose of FFP required depends on clinical conditions and
patients’ weight. Initial dose of 10-15 ml/kg body weight is usually given. As this is an
empirical dose, laboratory test should be used to monitor the efficacy and the result of
these tests as well as the patients’ clinical response should guide any further dosing
requirement.
ABO compatible FFP should be used. In case of emergency
patients group is not known, then group AB plasma may be safely given.
3
Rh-D compatible plasma should be given to women of child bearing age. Special
paediatric packs of FFP which contain small volume than standard FFP should be used
in treatment of neonatal DIC (2).
FFP must be administered through a standard administration set to remove debris or
small clots. FFP may be rapidly transfused for 20-30 minutes. The rate is mainly
limited by patients’ ability to tolerate the volume.
2.4 ADVERSE EFFECTS OF FFP

Plasma is capable of transmitting viruses like HIV, Hepatitis B Virus and Parvo
Virus.

FFP is also most likely to be responsible for the occurrence of transfusion
related acute lung injury (TRALI) (6).

Risk of volume overload due to protein content.

Allergic anaphylactic transfusion reaction with rapid transfusion rate (7).

Antibody induced complications like haemolytic reactions.
2.5. EFFECTIVENESS OF FFP
Effectiveness of FFP depend on the severity of bleeding diathesis, the underlying
etiology and tolerance of patient to large volume of FFP.Patients with impaired cardiac
or renal functions are susceptible to volume overload thus particular attention should
be paid to both the total volume infused and the rate of infusion. (8)
A retrospective analysis done at Govt. Medical College Hospital Blood Centre over a
14th month period showed Disseminated intravascular coagulation, chronic liver
disease, blunt trauma and septicemia were the common indications for FFP transfusion
in ICU setting. (9)
Use of FFP as nutritional supplement in patient undergoing gastrointestinal surgery has
been studied by Chatterjee M et al. (10)
4
In another prospective study in the ICU settings, FFP was given as prophylaxis, for
example prior to central venous cannulation or other invasive procedures. (1)
3. AIMS AND OBJECTIVES OF THE STUDY
Primary objective
1. To study indications of FFP transfusion and the number of FFP transfused in
patients admitted to ICU
Secondary Objective
1. To assess the effectiveness of the FFP transfusion by Prothrombin time( INR) &
Activated Partial Thromboplastin Time estimation.
2. To document the adverse effect if any of FFP transfusion.
4.DESIGN OF STUDY:
4.1 INCLUSION CRITERIA
All adult patients (more than 18 years) admitted to ICU requiring
FFP transfusion will be included in the study.
4.2 EXCLUSION CRITERIA
All patients (less than 18years) admitted to ICU requiring FFP
transfusion will be excluded in the study.
4.3 MATERIALS AND METHODS
The study is for a period of one year from January 2009 to December 2009.
clinical details regarding patients presenting problems, reasons for FFP request, number
of unit transfused, coagulation parameters of the patient and final outcome of patient
will be studied. Blood bank records will be reviewed for FFP requested from ICU.
The coagulation studies such as PT, APTT, INR will be performed on
automated coagulometers using citrated plasma sample of ICU patient receiving FFP.
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REFERENCES:
1. Simon JS. The evidence based use of FFP and Cryoprecipitate for
abnormalities of
coagulation test and clinical coagulopathy – American society of
haematology
education program book ; 2007:179-184.
2. Joseph JE, Machin, SJ. Inherited and acquired coagulation disorders. In : Murphy
MF, Pamphilon DH editor. Practical transfusion medicine. 1st ed. London: Black
Well Science Ltd; 2001:134-36.
3. Plasma component – Circular of information for the use of human blood and blood
components. In: Blood bank operation manual 1998 AABB. Bethseda :15.
4. Patricia AW. Donor selection and component preparation. In: Harmening DM
editor . Modern blood banking and transfusion practices. 3rd Ed. New Delhi: Jaypee
brothers Medical Publishers (P) Ltd;1998:230.
5. Chng WJ, Tan MK, Ponnudurai K. An audit of fresh frozen plasma usage in an
Acute general hospital in Singapore. Singapore Medical Journal 2003;
Vol44(II):574-78.
6. Linda stehling, Zauder HL. Fresh plasma – indication for use. In: Spiess BD, Counts
RB, Gould SA. Editor Perioperative transfusion medicine, 1st Ed.USA: Williams
&wilkins;1998:372-79.
7. Susan Knowles. Transfusion products in: Jennifer Duguid, Goodnough LT,
Desmond MJ editor. Transfusion medicine in practice, 1st Ed. London: Martin
Dunitz Ltd; 2002:39.
8. Bucur SZ, Hillyer CD. Fresh Frozen plasma and related products. In:Hillyer CD,
Strobl FJ, Hillyer KL, Jefferies LC, Silberstein LE editor. Handbook of transfusion
medicine, 1st Ed. USA: Academic press; 2001:42-44.
9. Basu S,Marwaha N. Fresh Frozen plasma – Indications and patterns of usage. Indian
journal of Haemotology and blood transfusion 2001 :June 19(2);51-2.
10. Chatterjee M, Bharucha ZS. Retrospective audit of transfusion practice in surgical
oncology. Indian journal of haematology & blood transfusion. 1998 :(16);107-112
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SIGNATURE OF THE
CANDIDATE
:
NAME AND DESIGNATION
:
OF THE GUIDE
DR. PARIMALA PUTTAIAH,
DCP, TUTOR,
DEPT OF CLINICAL PATHOLOGY
ST. JOHN’S MEDICAL COLLEGE,
BANGALORE – 34.
SIGNATURE AND
:
COMMENTS
HEAD OF DEPARTMENT
:
DR. KARUNA RAMESH KUMAR,
MD, DCP, PHD.
PROFESSOR AND HEAD DEPT OF CLINICAL
PATHOLOGY
ST. JOHN’S MEDICAL COLLEGE,
BANGALORE – 34.
SIGNATURE.
:
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