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A randomized controlled trial of fresh frozen plasma for coagulopathy in Russell's viper (Daboia russelii) envenoming
Isbister GK, Jayamanne S, Mohamed F, Dawson AH, Maduwage K, Gawarammana I, Lalloo DG, de Silva HJ, Scorgie FE, Lincz LF, et al
Journal of Thrombosis and Haemostasis : Jth. 2017;15((4):):645-654
Abstract
BACKGROUND Russell's viper (Daboia russelii) envenoming is a major health issue in South Asia and causes venom induced consumption coagulopathy (VICC). OBJECTIVES We investigated the effect of fresh frozen plasma (FFP) and two antivenom doses in correcting VICC. METHODS We undertook an open-label randomized controlled trial in patients with VICC at two Sri Lankan hospitals. Patients with suspected Russell's viper bites and coagulopathy were randomly allocated (1:1) high-dose antivenom (20 vials) or low-dose antivenom (10 vials) plus 4U FFP. The primary outcome was the proportion of patients with an international normalized ratio (INR)<2, 6h post-antivenom. Secondary outcomes included anaphylaxis, major haemorrhage, death and clotting factor recovery. RESULTS From 214 eligible patients, 141 were randomized; 71 to high-dose antivenom, 70 to low-dose antivenom/FFP; five had no post-antivenom bloods. The groups were similar except for a delay of 1h in antivenom administration for FFP patients. 6h post-antivenom 23/69 (33%) patients allocated high-dose antivenom had an INR<2 compared with 28/67 (42%) allocated low-dose antivenom/FFP [absolute difference 8%;95%Confidence Interval:-8% to 25%]. 15 patients allocated FFP did not receive it. Severe anaphylaxis occurred equally frequently in each group. One patient given FFP developed transfusion related acute lung injury. Three deaths occurred in low-dose/FFP patients including one intracranial haemorrhage. There was no difference in recovery rates of INR or fibrinogen, but more rapid initial recovery of factor V and X in FFP patients. CONCLUSION FFP post-antivenom in Russell's viper bites didn't hasten recovery of coagulopathy. Low-dose antivenom/FFP did not worsen VICC, suggesting low-dose antivenom is sufficient. This article is protected by copyright. All rights reserved.
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VWF cleaving protease activity and inhibitors in patients with thrombotic thrombocytopenic purpura (TTP) treated with INTERCEPT FFP vs. conventional FFP: results of a phase III trial
Conlan MGC, Corash L, Lin JS, Mintz PD, Neff AT, Malcolm MR, Hillyer CD, Goodnough LT,, et al.,
Vox Sanguinis. 2005;89((S2):):40. Abstract No. 5P-046.
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vWF cleaving protease activity and inhibitors in patients with thrombotic thrombocytopenic purpura (TTP) treated with INTERCEPT FFP vs. conventional FFP: results of a phase III trial
Conlan MG, Corash L, Lin J, Mintz PD, Neff AT, MacKenzie M, Hillyer CD, Goodnough LT,, et al.,
Transfusion. 2005;45((s3):):30A.. Abstract No. S92-040G.
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Solvent detergent treated plasma: an alternative to cryosupernant plasma in thrombotic thrombocytopenic purpura
Rock G, Moeslichan Mz S, Benny B, Clark W, Leblond P, Sutton D, Sternbach M, Wells G, Shumak K
Vox Sanguinis. 2005;89((S2):):11. Abstract No. 2PS-04-04.
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Does cryosupernatant plasma improve outcome in thrombotic thrombocytopenic purpura? No answer yet
Rock G, Anderson D, Clark W, Leblond P, Palmer D, Sternbach M, Sutton D, Wells G, Canadian Apheresis Group, Canadian Association of Apheresis Nurses
British Journal of Haematology. 2005;129((1):):79-86.
Abstract
A randomized prospective trial compared cryosupernatant plasma (CSP) to fresh frozen plasma (FFP) for treatment of thrombotic thrombocytopenic purpura (TTP). A total of 236 patients were required: 28 patients were treated with CSP and 24 with FFP within 30 months. There were no differences in survival at 1 month. By day 9, 17 of 26 patients with CSP and 18 of 24 with FFP had a platelet count >100 x 10(9)/l. At entry, von Willebrand factor (VWF) multimers were normal in all patients (range 1. 1-3. 95 IU/ml). ADAMTS-13 levels showed large variations ranging from 10% to 100% activity. At entry, no individual had <5% VWF cleaving protease. By day 9 (end of cycle), 89% (FFP) and 67% (CSP) had levels >50% of the controls. At 6 months some patients showed inhibitors to the enzyme in spite of adequate or normal platelet counts. The data from this study do not show an apparent advantage to the use of CSP in TTP. A large number of patients will be required to determine appropriate replacement therapy. We were not able to find a statistically significant relationship between the low level of protease activity at presentation of TTP and response.
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Treatment of thrombotic thrombocytopenic purpura using solvent detergent treated plasma
Rock G, Anderson D, Benny B, Clark W, Leblond P, Sutton D,, et al.,
Blood. 2005;106((11):): Abstract No. 3989.
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Cryoprecipitate poor plasma does not improve early response in primary adult thrombotic thrombocytopenic purpura (TTP)
Zeigler ZR, Shadduck RK, Gryn JF, Rintels PB, George JN, Besa EC, Bodensteiner D, Silver B, Kramer RE, North American TTP Group
Journal of Clinical Apheresis. 2001;16((1):):19-22.
Abstract
Thrombotic thrombocytopenic purpura (TTP) is a potentially fatal disease that is treated with plasma exchange and typically with replacement with fresh frozen plasma (FFP). This approach results in an approximate 50% response rate following 1 week of therapy and 80% survival. Cryoprecipitate poor plasma (CPP) is plasma from which the cryoprecipitate fraction is removed. CPP has been reported to be successful as salvage therapy in refractory TTP and has been suggested to be superior to FFP in retrospective studies. The present report compares initial therapy of TTP with exchange using replacement with either FFP or CPP in a multi-institutional prospective randomized study performed by the North American TTP Group (NATG Group) from 1993 to 1995. Initial therapy also included corticosteroids. Antiplatelet drugs or vinca alkaloids were not employed. A severity score index, response score, and individual clinical parameters (platelet count, LDH x upper limit of normal, hemoglobin level, and creatinine) were compared at their nadir or peak values, baseline, and days +6 and +13 of therapy. Thirteen patients were randomized to FFP exchange and 14 to CPP exchange. Results were equivalent for all parameters. Survival was equal with three deaths in each group. These data indicate that the efficacy of FFP and CPP are the same in the initial treatment of TTP in adults.
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Cryosupernatant plasma effectively reduces the levels of von Willebrand Factor and Factor VIII in the treatment of thrombotic thrombocytopenic purpura but metalloprotease concentrations vary
Rock GA, Ahluwalia N, Anderson D, Benny B, Buskard N, Leblond P,, et al.,
Transfusion. 2001;41((Suppl):):40S.. Abstract No. S143-040L.
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9.
SD Plasma in TTP and coagulation factor deficiencies for which no concentrates are available
Horowitz MS, Pehta JC
Vox Sanguinis. 1998;74((Suppl 1):):231-235.
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10.
Solvent detergent-treated plasma versus fresh frozen plasma in patients with thrombotic thrombocytopenic purpura
Sacher R, Pehta J, Zarou C, Moake J
Transfusion. 1996;36((9S):):63S.. Abstract No. S252.