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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 : 1 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%) 2 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. 5 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 6 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. : 7