|Year : 2019 | Volume
| Issue : 2 | Page : 175-179
Critical audit of fresh frozen plasma transfusion practices in obstetric and gynecology departments in a tertiary care hospital – Where and what needs to be improved?
Vandana Puri1, Ipsita Dhal2, Kalpana Singh1, Geetika Sharma1, Preeti Rai1, Sunita Sharma1
1 Department of Pathology, Lady Hardinge Medical College, New Delhi, India
2 Department of Pathology, Homi Bhaba Cancer Hospital, Varanasi, Uttar Pradesh, India
|Date of Submission||08-Aug-2019|
|Date of Acceptance||20-Sep-2019|
|Date of Web Publication||17-Oct-2019|
Dr. Ipsita Dhal
Department of Pathology, Homi Bhaba Cancer Hospital, Varanasi, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Introduction: Fresh frozen plasma (FFP) prepared from whole blood contains plasma proteins and all the coagulation factors including factor V and factor VIII. Many FFP transfusion guidelines have been published till now. However, the administration is inappropriate without any scientific basis or clinical indication in many hospital settings. Aims and Objectives: A retrospective study was carried out between February 2016 and August 2016 in the regional blood transfusion center of our institution to assess the appropriate usage of FFP in obstetrics and Gynecology. It was done using the FFP transfusion guidelines based on the British Committee for Standards in Hematology and College of American Pathologists. Materials and Methods: Blood bank requisition forms received from patients of obstetrics and gynecology department during this period were screened. Indications for transfusion requests were studied and further divided into appropriate and inappropriate requests. Results: A total of 901 units of FFP were issued to 250 patients during this period. Appropriate usage of FFP was found in 67% and inappropriate usage in 33% of the 250 patients evaluated. Bleeding related to surgery with deranged coagulation profile constituted the most common appropriate indication for FFP infusion, and severe anemia was the most inappropriate indication for FFP use. Conclusion: The usage of FFP requires a proper understanding and knowledge about the appropriate and inappropriate usages. It also involves training and supervising the medical staff at regular intervals. Computerized audit programs are required to do a prospective monitoring of the FFP issue and usage in any clinical setting. Further studies are required on the usage of FFP specifically in obstetric and gynecology patients to improve the utilization of this precious blood product.
Keywords: Appropriate uses, fresh frozen plasma, obstetrics and gynaecology patients
|How to cite this article:|
Puri V, Dhal I, Singh K, Sharma G, Rai P, Sharma S. Critical audit of fresh frozen plasma transfusion practices in obstetric and gynecology departments in a tertiary care hospital – Where and what needs to be improved?. Glob J Transfus Med 2019;4:175-9
|How to cite this URL:|
Puri V, Dhal I, Singh K, Sharma G, Rai P, Sharma S. Critical audit of fresh frozen plasma transfusion practices in obstetric and gynecology departments in a tertiary care hospital – Where and what needs to be improved?. Glob J Transfus Med [serial online] 2019 [cited 2019 Nov 12];4:175-9. Available from: http://www.gjtmonline.com/text.asp?2019/4/2/175/269393
| Introduction|| |
Fresh frozen plasma (FFP) is a component that is prepared within 6 h of blood collection and is frozen to −30°C or below. It contains plasma proteins and all the coagulation factors including factor-V and factor-VIII. Stringent guidelines have been set for the utilization of FFP. However, in the current clinical practice, the indiscriminate use of FFP is rampant. Its use in present-day hospital practice has significantly increased in the past few decades and it continues to increase. In many instances, it has been administered inappropriately without any scientific basis or clinical indication. The use of FFP shows substantial disparities between different hospitals, different clinical departments, and even within the same group of patients., Unnecessary use of FFP is known to increase the risk of adverse transfusion events as well as the health expenditure of the patients. The most common adverse events are allergic reactions, anaphylaxis, transfusion-related acute lung injury, and hemolysis resulting from transfused antibodies against blood group antigens. In addition, it carries the risk of transfusion transmitted infections such as HIV, hepatitis virus, and syphilis. Therefore, it is essential to weigh the risks of FFP transfusion against the benefits to the patients.
Obstetrics and gynecology constitute the major departments for the utilization of various blood components. The main components are packed red cells and FFP. The suppression of fibrinolytic system increases susceptibility to hemorrhage, particularly during labor which constitutes the main indication of FFP in obstetric practice. In gynecological practices, the major indications requiring various blood component transfusions are menorrhagia, hysterectomy, and surgery for neoplasms of the reproductive organs.
Aims and objectives
In our country, very few studies have been done regarding the clinical use of FFP in obstetrics and gynecological practices. In our study, the aim is to analyze the current use of FFP in the obstetrics and gynecology departments of our hospital and to do its audit for transfusion as well as their hemovigilance system. This study helped in defining the quality gap in demand and the need of FFP transfusion.
| Materials and Methods|| |
This retrospective study was carried out in our institution, which is a 1227-bedded hospital, which predominantly caters the need of majority of the obstetric and gynecology patients. All the female patients who were admitted to the obstetrics and gynecology department of our hospital and received FFP transfusion between the period of February 2016 and August 2016 were included in the study. The audit was done using the FFP transfusion guidelines based on the British Committee for Standards in Hematology (BCSH) and College of American Pathologists (CAP) [Table 1].,
|Table 1: Fresh frozen plasma transfusion guidelines based on the British Committee for Standards in Hematology, 2004, and College of American Pathologist, 1994|
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Blood bank requisition forms received from patients of obstetrics and gynecology department during this period were screened. The demographic data of the patients who received FFP transfusion were collected [Table 2]. Their hemoglobin and platelet counts, blood group, coagulation profile, clinical diagnosis, bleeding history if any, indication for FFP transfusion, and the number of units transfused were obtained from the forms. The patient's identity was not disclosed. The patients who had missing data were excluded from the study. Indications for transfusion requests were evaluated and were divided into various diagnostic categories, which were further classified into appropriate and inappropriate requests [Table 3].
|Table 2: Demographic characteristics and laboratory parameters of the patients|
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| Results|| |
The approximate number of FFP transfusions in our hospital is about 5000–5500 units per year. During our study period, we received a total of 1011 requisitions for different blood components from the department of obstetrics and gynecology. A total of 901 units of FFP were issued to 250 patients. [Table 2] shows the clinical details and demographic data of the patients. The average patient age was 27 years, and the maximum and minimum ages of patients were 60 years and 18 years, respectively. Active bleeding was present in 168 of 250 patients. [Figure 1] shows the indications of FFP requests for patients with massive active bleeding; mean hemoglobin value was 7.3 g/dl. Deranged coagulation profile was observed in 9 of these 250 patients. Majority of the patients were of blood Group O (99/250) followed by B (86/250), A (40/250), and AB (25/250). Of these 901 units of FFP, replacement donation was done only for 382 (42%) patients. The rest 519 (58%) units were issued on undertaking. Two hundred twenty-five patients (90%) of those 250 patients received other blood components, such as red cells and platelet concentrates concurrently, while 25 patients (10%) were given only FFP. Based on the published guidelines, appropriate usage of FFP was found in 168 patients (67%) and inappropriate usage in 82 patients (33%) of the 250 patients evaluated. [Table 3] lists an analysis of appropriateness of FFP transfusion for various indications. Bleeding related to surgery such as lower uterine segment caesarean section (LSCS), cancer surgery, and hysterectomy with deranged coagulation profile constituted the most common appropriate indication for FFP infusion (42 of 168 patients). Severe anemia was the most inappropriate indication for FFP use (33 of 82 patients). Of 250 patients who were transfused FFP, mortality rate was found to be 1.6% (4 cases) which was not significant.
|Figure 1: Fresh frozen plasma requests for patients with active bleeding (total = 168)|
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| Discussion|| |
There has been a dramatic increase in the use of FFP in the past few years despite the lack of appropriate clinical indications for its usage, possibly due to the availability of sophisticated blood banking services. However, in a developing country like India where the supply of blood and blood components are limited, a high rate of irrational use of FFP will lead to a major impact on the health-care expenditure of the country, wastage of resources, transmission of many viral infections, and depriving more needy patients leading to increased morbidity and mortality rates. Therefore, the indications for the use of FFP must be justified on clinical grounds. Various studies have reported a very high incidence of inappropriate use of FFPs in spite of many formulated guidelines for its use.,,, Many patients who receive FFP can be managed more effectively and safely with alternative modalities of treatments. The high rate of injudicious use reflects the uncertainty among the treating physicians about the appropriate clinical indications for its usage. Another reason may be the misconception regarding its effectiveness as a hemostatic agent.
Our hospital being one of the largest gynecology hospitals of North India, greater proportion of transfusions are given to women with obstetric and gynecological emergencies. Acute blood loss is one of the main causes of maternal mortality. Obstetric bleeding may be massive and life-threatening. Therefore, the real cause of bleeding must be identified and treated accordingly. Pregnancy is a hypercoagulable state, which requires the replacement of clotting factors. To prevent coagulation defects arising from stored red blood cell, one unit of FFP should be transfused per 4–6 units of packed red cells. Widespread use of FFP in non-bleeding patients needs careful scrutiny. Moreover, thousands of pregnancy-related deaths could be avoided each year through access to safe blood.
The pattern of blood usage is different in different countries due to varied diagnostic and treatment options. [Table 4] shows the comparative analysis of various FFP audits done in India. These audits have been conducted on a broad range of medical and surgical patients. Our study differs from all others since it exclusively studied the FFP usage of only obstetric and gynecology patients. The current study has therefore documented the current practices of usage of FFP to formulate policies and strategies, to minimize unnecessary transfusions, and to ensure safe and rational use of FFP in these patients. To the best of our knowledge, no similar study has been documented in literature till date.
|Table 4: Comparison of studies by different Indian authors on appropriate usage of fresh frozen plasma|
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In the present study, a total of 901 units of FFP were given to the patients of obstetric and gynecology departments of an average age of 27 years. The most common indications for the demand of FFP were postpartum hemorrhage and preoperative correction of anemia, similar to that of study by Agrawal et al. in 2013. The appropriateness of FFP was found to be 67%, which was concordant with the study by Makroo et al. and Eagleton et al. which showed 69.8% and 66% appropriateness, respectively. A similar study conducted by Hui et al. in 2005 shows 72% appropriateness. A study by Jayanthi and Pitchai in 2015 shows that in 74% of cases, the indications for FFP use were appropriate. FFP usage was reported as appropriate in only 29.5% by Chaudhary et al., which was significantly less than that of our study. Similar to our study, Pahuja et al. applied the criteria set by the BCSH and CAP, and only 22% of the FFP transfusion episodes were deemed appropriate. Kulkarni in 2012 and Vaidehiet al. in 2015 also found that the inappropriateness in FFP usage was more common (52% and 62%, respectively). The discrepancy between the results may be due to differences in transfusion guidelines used as reference, the number of centers included in the study, and inclusion of patients of more than one clinical department. Different clinical algorithms may have caused a difference in FFP usage, thus affecting the final results of these studies.
A prospective study done by Kakkar et al. in 2004 showed that 60.3% of the FFP demands were inappropriate according to the BCSH guidelines. Then, they performed a re-audit after an educational campaign, and the inappropriate usage of FFP showed a significant reduction by 26.6%. In their study, the major causes of misuse were hypoproteinemic states (40.5%) and anemia (36.5%).
In our study, we found that severe anemia with anticipated bleeding was the most common inappropriate indication for which clinicians demanded FFP. The reason is a common notion among the treating obstetricians and gynecologists as well as the anesthetist to prevent any future bleeding episodes during surgery due to deranged coagulation by transfusing FFP beforehand. After our study results, this issue was discussed in several committee meetings, and the appropriate measures were decided to be taken to prevent this rampant misuse of FFP. We searched several literatures and found that till now none of has studied the usage of FFP specifically in obstetric and gynecologic practice, which makes our study even more unique.
Our study is a single-centered, retrospective study. Another major limitation of our study was the unavailability of the posttransfusion prothrombin time, a partial thromboplastin time, and international normalized ratio values in the patients transfused with FFP, which would have been more useful. Moreover, as this study was done back in 2016, we had 42% of replacement donors, and through this study, we again will emphasize that voluntary donation is the need of the hour and we should resort to 100% voluntary blood donation.
| Conclusion|| |
The appropriate usage of FFP requires a proper understanding of the properties and clinical utility of FFP, as well as the knowledge about the risks and complications of its usage. The risks associated with it can only be reduced by close collaboration between the clinicians and the blood transfusion services. As well as the guidelines of FFP usage must be available to the end users. A transfusion audit is necessary to access the blood utilization pattern in any hospital and to ensure its appropriate use and is an important part of the quality assurance program that can provide necessary information for the improvement of transfusion practices. It is also a management tool for the appraisal and justification of the appropriateness and efficiency of transfusion therapy. Although it is difficult to do a prospective monitoring due to shortage of staff and time, this problem can be overcome by computerized audit programs. Moreover, these observations will help us in refining the institutional policies regarding FFP usage. Training and supervising the medical staff at regular intervals should be done. Apart from that, regular screening of the requisition forms by the blood bank doctors is necessary. We feel that further studies are required on the usage of FFP specifically in obstetric and gynecology patients to improve the utilization of this precious blood product. All these will go a long way in ensuring the rational use of FFP in these patients.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Shinagare SA, Angarkar NN, Desai SR, Naniwadekar MR. An audit of fresh frozen plasma usage and effect of fresh frozen plasma on the pre-transfusion international normalized ratio. Asian J Transfus Sci 2010;4:128-32.
] [Full text]
Katara AA, Agravat AH, Dhruva G, Dalsania JD, Dave RG. An audit of appropriate usage of blood products in blood bank in a tertiary care hospital Rajkot. Int J Curr Res Rev 2014;6:3740.
O'Shaughnessy DF, Atterbury C, Bolton Maggs P, Murphy M, Thomas D, Yates S, et al.
Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol 2004;126:11-28.
Practice parameter for the use of fresh-frozen plasma, cryoprecipitate, and platelets. Fresh-frozen plasma, cryoprecipitate, and platelets administration practice guidelines development task force of the college of American pathologists. JAMA 1994;271:777-81.
Kulkarni N. Evaluation of fresh frozen plasma usage at a medical college hospital – A two year study. Int J Blood Transfus Immunohematol 2012;2:56-9.
Kakkar N, Kaur R, Dhanoa J. Improvement in fresh frozen plasma transfusion practice: Results of an outcome audit. Transfus Med 2004;14:231-5.
Chaudhary R, Singh H, Verma A, Ray V. Evaluation of fresh frozen plasma usage at a tertiary care hospital in North India. ANZ J Surg 2005;75:573-6.
Makroo RN, Raina V, Kumar P, Thakur UK. A prospective audit of transfusion requests in a tertiary care hospital for the use of fresh frozen plasma. Asian J Transfus Sci 2007;1:59-61.
] [Full text]
World Health Organization. The Clinical Use of Blood, Handbook. WHO Blood Transfusion Safety. Publication WHO/BTS/99.3. Gevena: World Health Organization; 2001.
Lingegowda JB, Jeyakumar JD, Muddegowda PH, Pitchai R, Gopal N, Sinha P, et al.
An audit of requests for fresh frozen plasma in a tertiary care center in South India. J Lab Physicians 2016;8:41-4.
] [Full text]
Patel V, Gajjar M, Bhatnagar N, Shah M, Shah M, Lahre S. An audit of plasma usage in tertiary care hospital. Int J Biomed Adv Res 2015;6:331-3.
Agarwal N, Subramanian A, Pandey RM, Albert V, Karjee S, Arya V. An audit of fresh frozen plasma usage in a tertiary trauma care centre in North India. Indian J Hematol Blood Transfus 2014;30:328-32.
Agrawal VP, Akhtar M, Mahore SD. A retrospective clinical audit of blood transfusion requests in tertiary care hospital. Int J Biomed Adv Res 2013;4:657-60.
Eagleton H, Benjamin S, Murphy MF. Audits of appropriate use of FFP. Blood Matters 2000;4:5-8.
Hui CH, Williams I, Davis K. Clinical audit of the use of fresh-frozen plasma and platelets in a tertiary teaching hospital and the impact of a new transfusion request form. Intern Med J 2005;35:283-8.
Pahuja S, Sethi N, Singh S, Sharma S, Jain M, Kushwaha S, et al.
Concurrent audit of fresh frozen plasma: Experience of a tertiary care hospital. Hematology 2012;17:306-10.
Jayanthi N, Pitchai R. Audit of fresh frozen plasma usage and study the effect of fresh frozen plasma on the pre transfusion and post – Transfusion international normalized ratio. Int J Curr Med Appl Sci 2015;7:34-9.
[Table 1], [Table 2], [Table 3], [Table 4]