Prothrombin Complex Concentrate Versus Fresh Frozen Plasma for Vitamin K Antagonist Reversal in Acutely Bleeding Patients: A Retrospective Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3830-3830
Author(s):  
Martin H. Ellis ◽  
Orly Avnery ◽  
Leticia Aizenberg ◽  
Muhamad Mahamid

Abstract Introduction Vitamin K antagonist (VKA) drugs require immediate reversal in VKA-treated patients with major bleeding or requiring urgent surgery. 4-factor prothrombin complex concentrates (PCCs)are approved for urgent VKA reversalbecause they reverse the international normalized ratio (INR) more rapidly than fresh frozen plasma (FFP). Studies comparing the clinical benefits of PCC and FFP have focused on VKA reversal prior to urgent surgery. Few data comparing laboratory and clinical outcomes of patients receiving PCC or FFP for major hemorrhage have been published, and these pertain to intracranial hemorrhage (ICH) only. Given the complexity of performing randomized studies in this setting, observational studies are relevant to inform on this issue. AIMS To compare the effects of PCC versus FFP on patient outcomes in VKA-associated major hemorrhage. The primary outcomes were the rate of INR reversal and blood product utilization. The secondary outcome was duration of intensive care and total hospital admission. Methods We performed a retrospective, single-center study of consecutive unselected patients receiving a 4-factor PCC for VKA reversal because of hemorrhage between January 2012 and April 2015 compared to consecutive unselected patients treated with FFP for the same indication from January 2010-December 2011, a period prior to introduction of PCC at the Meir Medical Center. Patients were identified by review of clinical and blood bank electronic medical records. We analyzed patient demographics, indication for VKA, underlying illnesses, aspirin use, site and severity of hemorrhage, INR pre- and post reversal, rate of INR reversal, transfusion requirements and duration of hospitalization, treatment. Results 56 patients received PCC and were compared to 56 patients treated with FFP. In the PCC group 17 patients had ICH and 25 had gastrointestinal hemorrhage compared to 17 and 31 patients respectively in the FFP group. Patients were adjusted for age, sex, presence of renal failure, active cancer, aspirin use, site of hemorrhage, pre-treatment INR and hemoglobin concentration and hemorrhagic shock at presentation. Outcomes: Median time to INR of ≤1.3 was 0.5 (range 0.5-1.5) vs 15.5 (range 5-96) hours for PCC vs FFP respectively, P<0.001). Packed red cell transfusion did not differ between the groups: median =1(range 0-13) in the PCC group and median= 2(range=2-10) in the FFP group (P=0.3), but more FFP was transfused in the FFP vs PCC group median =0(range 0-8) in the PCC group and median= 4(range=2-8) in the FFP group (P<0.001). Duration of hospital admission was longer in the FFP (median=7 days, range 1-93) vs PCC patients (median =6 days, range=1-35) (P=0.04). Conclusion This is the first observational study comparing PCC and FFP for VKA-related hemorrhage to our knowledge and the first study of PCC versus FFP for extracranial VKA-related hemorrhage. PCC was more effective than FFP in for reversal of the INR and was associated with less overall FFP use but not packed red cell transfusion. Similarly hospital admission duration was shorter among the PCC patients. Larger studies are required to determine whether PCC confers other clinical benefits over FFP for VKA reversal in acutely bleeding patients. Disclosures Ellis: Boehringer Ingelheim: Speakers Bureau; Bayer: Speakers Bureau; Pfizer: Speakers Bureau.

1993 ◽  
Vol 21 (2) ◽  
pp. 156-162 ◽  
Author(s):  
M. D. Nicholls ◽  
G. Whyte

Hypothetical clinical cases were used to investigate transfusion-related decision-making. Three red cell, three fresh frozen plasma (FFP) and three albumin transfusion decision cases were administered by questionnaire to 228 medical staff. The transfusion decision triggers were identified and comparisons made between resident and specialist groups and between Melbourne and Sydney participants. Factors important in red cell transfusion decisions included haemoglobin, symptoms of anaemia, presence of co-morbidities or surgery, gender, period of hospitalisation and the degree of documented blood loss. FFP administration was influenced by an abnormal coagulation test, the presence of co-morbidities and by the number of red cell units transfused. The administration of albumin, concentrated or 5% SPPS, was influenced by the period of hospitalisation and clinical circumstances such as a falling urine output postoperatively, and by the presence of hypotensive complications. Different transfusion responses were noted: resident staff transfused red cells and FFP earlier than specialists; Sydney specialists were more conservative of red cell transfusion; Melbourne specialists more conservative of FFP administration and surgeons were four times more likely to transfuse patients than physicians or anesthetists at certain haemoglobin values.


2021 ◽  
Vol 47 (01) ◽  
pp. 074-083
Author(s):  
Kathryn W. Chang ◽  
Steve Owen ◽  
Michaela Gaspar ◽  
Mike Laffan ◽  
Deepa R. J. Arachchillage

AbstractThis study aimed to determine the impact of major hemorrhage (MH) protocol (MHP) activation on blood administration and patient outcome at a UK major cardiothoracic center. MH was defined in patients (> 16 years) as those who received > 5 units of red blood cells (RBCs) in < 4 hours, or > 10 units in 24 hours. Data were collected retrospectively from patient electronic records and hospital transfusion databases recording issue of blood products from January 2016 to December 2018. Of 134 patients with MH, 24 had activated MHP and 110 did not have activated MHP. Groups were similar for age, sex, baseline hemoglobin, platelet count, coagulation screen, and renal function with no difference in the baseline clinical characteristics. The total number of red cell units (median and [IQR]) transfused was no different in the patients with activated (7.5 [5–11.75]) versus nonactivated (9 [6–12]) MHP (p = 0.35). Patients in the nonactivated MHP group received significantly higher number of platelet units (median: 3 vs. 2, p = 0.014), plasma (median: 4.5 vs. 1.5, p = 0.0007), and cryoprecipitate (median: 2 vs. 1, p = 0.008). However, activation of MHP was associated with higher mortality at 24 hours compared with patients with nonactivation of MHP (33.3 vs. 10.9%, p = 0.005) and 30 days (58.3 vs. 30.9%, p = 0.01). The total RBC and platelet (but not fresh frozen plasma [FFP]) units received were higher in deceased patients than in survivors. Increased mortality was associated with a higher RBC:FFP ratio. Only 26% of patients received tranexamic acid and these patients had higher mortality at 30 days but not at 24 hours. Deceased patients at 30 days had higher levels of fibrinogen than those who survived (median: 2.4 vs. 1.8, p = 0.01). Patients with activated MHP had significantly higher mortality at both 24 hours and 30 days despite lack of difference in the baseline characteristics of the patients with activated MHP versus nonactivated MHP groups. The increased mortality associated with a higher RBC:FFP ratio suggests dilutional coagulopathy may contribute to mortality, but higher fibrinogen at baseline was not protective.


2011 ◽  
Vol 70 (1) ◽  
pp. 90-96 ◽  
Author(s):  
Ross Davenport ◽  
Nicola Curry ◽  
Joanna Manson ◽  
Henry DeʼAth ◽  
Amy Coates ◽  
...  

1981 ◽  
Author(s):  
D C Case

A 25-year old male was admitted for an episode of right sided headache and subsequent generalized seizure. On admission his temperature was 37.6°. He had generalized petechiae and conjunctival hemorrhages. Organomegaly and lymphadenopathy were absent. There was mild left sided weakness. The Hgb. was 6.9 g/dl., reticulocyte count 10%, WBC 11,500/mm3, and platelet count 10,000/mm3. There were numerous schistocytes on the peripheral smear; bone marrow revealed panhyperplasia. Coagulation studies were normal. The BUN was 30, and the creatinine 1.7 mg/dl. Plasma was positive for Hgb. CT scan was negative for gross intracranial bleeding. The diagnosis of T.T.P. was made. On admission, the patient received 10 units of platelets and 2 units of packed red blood cells. He did not require further red cell or platelet transfusions during the rest of his hospital course. He was then started on infusions of fresh-frozen plasma. He then received one unit every 3 hours for 6 days, one unit every 6 hours for 2 days, then one unit every 12 hours for 2 days and finally 1 unit daily for 5 days. The response was immediate. After the infusions were started, the hematologic parameters steadily improved. The patient’s hematuria rapidly improved. Further CNS symptoms did not appear. The patient’s Hgb. was 12 g/dl, and reticulocyte count was 2.5% by the 9th day. His platelet count was normal by the 4th day. The patient was discharged on the 15th day. Infusions of plasma were discontinued at the time of discharge. The patient required plasma therapy 4 weeks later for recurrent thrombocytopenia (50,000/mm3). The patient has remained normal for 9 months since therapy and further plasma has not been required. Primary plasma therapy for T.T.P. as sole treatment should be further studied.


2017 ◽  
Vol 37 (2) ◽  
pp. 49-56
Author(s):  
Sherri Ozawa ◽  
Tiffany Nelson

Management of patients receiving anticoagulants is a major factor in achieving better outcomes. Anticoagulant therapy may need to be discontinued or rapidly reversed before urgent surgery or invasive procedures. In these situations, treatment with concentrated vitamin K, fresh frozen plasma, and/or clotting factors can achieve more rapid anticoagulant reversal than can drug discontinuation alone. Activated prothrombin complex concentrate is used to treat hemophiliac patients with acquired factor VIII inhibitors. Nonactivated prothrombin complex concentrates are used for anticoagulant reversal. The concentrates are effective within minutes of dosing, providing a nearly immediate decrease in the international normalized ratio. The concentrates are lyophilized powders that can be quickly reconstituted, do not require ABO blood typing before use, and contain 25 times the concentration of vitamin K–dependent clotting factors compared with fresh frozen plasma. Studies suggest that the concentrates are associated with better clinical end points than is fresh frozen plasma.


Sari Pediatri ◽  
2016 ◽  
Vol 13 (3) ◽  
pp. 159
Author(s):  
Yetty Movieta Nency ◽  
Dana Sumanti

Latar belakang.Aplikasi transfusi darah dalam klinis sehari-hari dapat sebagai terapi pengganti maupun suportif. Sesuai pertimbangan risiko dan manfaat tranfusi komponen darah seperti thrombocyt concentrate(TC) packed red cell(PRC), fresh frozen plasma(FFP), platelete rich plasma (PRP), dan cryoprecipitate/kriopresipitat lebih direkomendasikan daripada whole blood(WB). Tujuan.Mengetahui hubungan antara latar belakang penyakit dengan penggunaan transfusi komponen darah.Metode.Penelitian retrospekstif dilakukan di Ruang Anak Rumah Sakit Dr Kariadi Semarang. Data diperoleh dari register bank darah rumah sakit tahun 2008-2010. Latar belakang penyakit ditentukan dengan mengidentifikasi diagnosis pada setiap kasus transfusi. Komponen darah yang diteliti PRC, TC, FFP, PRP, dan kriopresipitat. Utilisasi dengan menghitung total jumlah komponen darah yang dipakai per diagnosis penyakit, dan rerata pemakaian produk darah per jumlah kasus terindikasi transfusi per tahun. Analisis uji statistik hubungan dengan menggunakan Chi square.Hasil.Terdapat peningkatan rerata utilisasi darah 5678 unit darah per tahun. Terdapat peningkatan penggunaan selama 3 tahun terakhir, secara berurutan adalah 3751, 6496, dan 6787 unit darah (p<0.001). Komponen darah yang paling banyak digunakan berturut-turut adalah TC 3228 unit, PRC 1682 unit, FFP 295 unit, PRP 224 unit, dan cryo133 unit. Pasien leukemia merupakan pengguna komponen darah terbanyak dengan rerata pemakaian per tahun 2098 unit, diikuti oleh sepsis 893 unit, dan thalassemia 568 unit. Rasio kebutuhan PRC terbanyak untuk kasus penyakit jantung (2,23) diikuti penyakit ginjal (2,25) dan thalassemia (1,7). Untuk penggunaan TC, terbanyak berturut-turut adalah ITP (14,70 unit), anemia aplastik (9,8 unit), dan leukemia (6 unit). Terdapat hubungan antara diagnosis penyakit dengan penggunaan transfusi komponen PRC, TC, dan plasma (p<0,001).Kesimpulan.Terdapat hubungan antara latar belakang penyakit penyebab dengan penggunaan transfusi komponen darah. Leukemia, sepsis, dan thalassemia adalah latar belakang penyakit yang paling banyak menggunakan transfusi komponen darah. Berturut turut komponen darah yang banyak digunakan adalah konsentrat trombosit, komponen sel darah merah, serta plasma darah segar.


Transfusion ◽  
2008 ◽  
Vol 48 (11) ◽  
pp. 2338-2347 ◽  
Author(s):  
Claire Wilsher ◽  
Margaret Garwood ◽  
Janet Sutherland ◽  
Craig Turner ◽  
Rebecca Cardigan

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