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Evaluation of effect of scheduled fresh frozen plasma on ECMO circuit life: A randomized pilot trial
McMichael ABV, Zimmerman KO, Kumar KR, Ozment CP
Transfusion. 2020
Abstract
BACKGROUND Factor consumption is common during ECMO complicating the balance of pro and anticoagulation factors. This study sought to determine whether transfusion of coagulation factors using fresh frozen plasma (FFP) increased ECMO circuit life and decreased blood product transfusion. Secondly, it analyzed the association between FFP transfusion and hemorrhagic and thrombotic complications. STUDY DESIGN AND METHODS Thirty-one pediatric ECMO patients between October 2013 and January 2016 at a quaternary care institution were included. Patients were randomized to FFP every 48 hours or usual care. The primary outcome was ECMO circuit change. Secondary outcomes included blood product transfusion, survival to decannulation, hemorrhagic and thrombotic complications, and ECMO costs. RESULTS Median (interquartile range [IQR]) number of circuit changes was 0 (0, 1). No difference was seen in percent days without a circuit change between intervention and control group, P = .53. Intervention group patients received median platelets of 15.5 mL/kg/d IQR (3.7, 26.8) vs 24.8 mL/kg/d (12.2, 30.8) for the control group (P = .16), and median packed red blood cells (pRBC) of 7.7 mL/kg/d (3.3, 16.3) vs 5.9 mL/kg/d (3.4, 18.7) for the control group, P = .60. FFP transfusions were similar with 10.2 mL/kg/d (5.0, 13.9) in the intervention group vs 8.8 (2.5, 17.7) for the control group, P = .98. CONCLUSION In this pilot randomized study, scheduled FFP did not increase circuit life. There was no difference in blood product transfusion of platelets, pRBCs, and FFP between groups. Further studies are needed to examine the association of scheduled FFP with blood product transfusion.
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Fresh frozen plasma prime and the level of gammaglobulin after pediatric cardiopulmonary bypass
Shabanian R, Dehestani A, Dadkhah M, Nikdoost A, Asbagh PA, Radmehr H, Rahimzadeh M, Oveisi S, Rezaei N, Ahani M, et al
American journal of clinical and experimental immunology. 2020;9(5):91-100
Abstract
Different organ perturbation and multiple complications might occur after cardiopulmonary bypass (CPB). A variety of solutions might be used for pump priming with different advantages and disadvantages. The advantage of fresh frozen plasma (FFP) inclusion in pump prime has been shown in post-CPB coagulation management. Acquired hypogammaglobulinemia is the disadvantage of albumin (ALB) pump prime. Our aim was to assess the impact of FFP prime on the post-pump serum level of immunoglobulin G (IgG) and its subclasses. Fifty-six patients under the age of 5 years old who were scheduled for cardiac surgery on CPB were randomly primed with FFP or ALB. Any innate or acquired immune deficiency was considered as exclusion criteria. The pre-CPB and 24-hour post-CPB collected blood samples were analyzed by the nephelometric method for the plasma level of IgG and its four subclasses. Twenty-two patients (mean age and weight of 13 months and 6.8 kilograms) in the ALB prime group and 26 patients (mean age and weight of 15 months and 8.1 kilograms) in the FFP prime group completed the study. Using paired t-test and repeated measures ANOVA test, patients in the ALB prime group had a significant drop in the post-CPB serum level of total IgG (597±138 mg/dL to 379±179 mg/dL, P value <0.001) and its two subclasses of IgG1 and IgG3. In contrast, there was a slight elevation in the serum level of total IgG (549±207 mg/dL to 630±180 mg/dL, P value =0.008) and its two subclasses of IgG2 and IgG4 in patients who had FFP prime solution. In conclusion, compared to the ALB prime solution, FFP inclusion in prime could hamper the pediatric post-CPB induced hypogammaglobulinemia.
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Early or late fresh frozen plasma administration in newborns and small infants undergoing cardiac surgery: the APPEAR randomized trial
Bianchi P, Cotza M, Beccaris C, Silvetti S, Isgro G, Pome G, Giamberti A, Ranucci M
British Journal of Anaesthesia. 2017;118((5)):788-796.
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Abstract
Background: In newborns and small infants undergoing cardiac surgery with cardiopulmonary bypass (CPB) and blood priming, it is unclear whether there is reduced blood loss if fresh frozen plasma (FFP) is added to the CPB priming volume. This single-centre, randomized trial tested the hypothesis that the administration of FFP after CPB (late FFP group) is superior to FFP priming (early FFP group) in terms of postoperative bleeding and overall red blood cell (RBC) transfusion. Methods: Seventy-three infants weighing <10 kg were randomly allocated to receive FFP to supplement RBCs in the CPB priming solution ( n =36) or immediately after CPB ( n =37). The primary endpoint was a difference in postoperative blood loss; secondary endpoints included the amount of RBCs and FFP transfused through the first 48 postoperative hours. Results: All patients were included in the analysis. Patients in the late FFP arm had greater postoperative mean blood loss than patients in the early FFP arm [33.1 ( sd 20.6) vs 24.1 (12.9) ml kg -1 ; P =0.028], but no differences in transfusions were found. The subgroup of cyanotic heart disease patients had comparable results, but with greater use of RBCs in the late FFP group. Conclusions: In infants undergoing cardiac surgery, FFP in the priming solution appears slightly superior to late administration in terms of postoperative bleeding. Clinical trial registration: www.ClinicalTrials.gov , NCT02738190.
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Prophylactic versus reactive transfusion of thawed plasma in patients undergoing surgical repair of craniosynostosis: a randomized clinical trial
Pieters BJ, Conley L, Weiford J, Hamilton M, Wicklund B, Booser A, Striker A, Whitney S, Singhal V
Paediatric Anaesthesia. 2015;25((3):):279-87.
Abstract
BACKGROUND Surgical repair of craniosynostosis in young children is associated with copious bleeding and often coagulopathy. Typically, a reactive transfusion strategy is used to treat coagulopathy whereby fresh frozen plasma (FFP) is given only after clinical manifestation of clotting abnormality. This prospective, randomized clinical trial was designed to test the hypothesis that prophylactic FFP during craniofacial surgery reduces blood loss and blood transfusion requirements compared to a reactive FFP transfusion strategy. METHODS Eighty-one patients less than 2 years of age requiring primary repair of craniosynostosis were randomized to receive FFP using either a prophylactic or reactive strategy. Laboratory values were measured at four standardized time points. The volume of blood products transfused, length of stay in the pediatric intensive care unit (PICU), hospital length of stay, and number of donor exposures were recorded for each patient. RESULTS The prophylactic FFP group received a significantly greater average volume of FFP compared to the reactive group (29.7 mlkg(-1) vs 16.1 mlkg(-1) ; P < 0.001), which was associated with improvement in coagulation values at multiple time points. However, there was no difference in blood transfusion requirements or blood loss between the two groups. The two transfusion strategies resulted in similar median donor exposures. There was no difference in PICU or hospital length of stay. CONCLUSION A reactive FFP transfusion strategy required less plasma transfusion and was associated with similar rates of blood loss and PRBC transfusion as prophylactic FFP despite improvement in coagulation values in the prophylactic FFP group.Copyright 2014 John Wiley & Sons Ltd.
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The influence of cardiopulmonary bypass priming without FFP on postoperative coagulation and recovery in pediatric patients with cyanotic congenital heart disease
Miao X, Liu J, Zhao M, Cui Y, Feng Z, Zhao J, Long C, Li S, Yan F, Wang X, et al
European Journal of Pediatrics. 2014;173((11):):1437-43.
Abstract
UNLABELLED Transfusion guidelines have been produced for the evidence-based use of fresh frozen plasma (FFP). However, the inappropriate use of FFP is still a worldwide problem, especially in the prophylactic settings. In the present study, 100 cyanotic pediatric patients (age 6 months to 3 years) undergoing cardiac surgery with cardiopulmonary bypass (CPB) were randomized to receive either 10-20 ml/kg FFP (FFP group, n=50) or 10-20 ml/kg 4 % succinylated gelatin (Gelofusine, GEL group, n=50) in the priming solution. Rapid thromboelastography (r-TEG) was measured before skin incision and 15 min after heparin neutralization. Postoperative renal and hepatic function, mediastinal chest tube drainage, transfusion requirements, and recovery time were observed. The relationships between hematologic and demographic data and postoperative bleeding volume were also analyzed. The results showed that there were significantly elevated levels of fibrinogen (r-TEG parameters: fibrinogen contribution to maximal amplitude (MAf) and fibrinogen level (FLEV)) in the FFP group compared to the GEL group. The postoperative blood loss, total transfusion requirements, and recovery time were not significantly different between the two groups, indicating that there were no obvious clinical benefits of using FFP in the priming. The maximal amplitude (MA) of r-TEG measured after heparin neutralization was correlated with the 6-h postoperative bleeding volume. In addition, preoperative fibrinogen level rather than FFP priming was an independent predictor of postoperative blood loss. CONCLUSION Prophylactic use of FFP in the priming solution does not have obvious clinical benefits in cyanotic congenital heart disease (CCHD) patients. Gelofusine, an artificial colloid, is a safe and effective substitute of FFP in the priming solution. Furthermore, r-TEG can be used as a "real-time" assessment tool to evaluate postoperative bleeding and guide transfusion after cardiac surgery in pediatric patients.
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Fresh frozen plasma in pump priming for congenital heart surgery: evaluation of effects on postoperative coagulation profiles using a fibrinogen assay and rotational thromboelastometry
Lee JW, Yoo YC, Park HK, Bang SO, Lee KY, Bai SJ
Yonsei Medical Journal. 2013;54((3):):752-62.
Abstract
PURPOSE In this prospective study, the effects of fresh frozen plasma (FFP) included in pump priming for congenital heart surgery in infants and children on post-bypass coagulation profiles were evaluated. MATERIALS AND METHODS Either 20% albumin (50-100 mL) or FFP (1-2 units) was added to pump priming for patients randomly allocated into control or treatment groups, respectively. Hematologic assays, including functional fibrinogen level, and rotational thromboelastometry (ROTEM) were measured before skin incision (baseline), after weaning from cardiopulmonary bypass (CPB) and heparin reversal, and at 24 hours (h) in the intensive care unit (ICU). RESULTS All the baseline measurements were comparable between the control and treatment groups of infants and children. After heparin reversal, however, significantly higher fibrinogen levels and less reduced ROTEM parameters, which reflect clot formation and firmness, were demonstrated in the treatment groups of infants and children. At 24 h in the ICU, hematologic assays and ROTEM measurements were comparable between the control and treatment groups of infants and children. Transfusion requirements, excluding FFP in pump prime, and postoperative bleeding were comparable between the control and treatment groups of infants and children. CONCLUSION Although clinical benefits were not clearly found, the inclusion of FFP in pump priming for congenital heart surgery in infants and children was shown to improve the hemodilution-related hemostatic dysfunction immediately after weaning from CPB and heparin reversal.
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Fresh frozen plasma does not reduce in vivo thrombin formation after neonatal cardiopulmonary bypass surgery
Långström S, Rautiainen P, Mildh L, Peltola K, Wartiovaara-Kautto U, Heikinheimo M, Petäjä J
Thrombosis and Haemostasis. 2008;100((6):):1207-8.
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High colloid oncotic pressure priming of cardiopulmonary bypass in neonates and infants: implications on haemofiltration, weight gain and renal function
Loeffelbein F, Zirell U, Benk C, Schlensak C, Dittrich S
European Journal of Cardio-Thoracic Surgery. 2008;34((3):):648-52.
Abstract
OBJECTIVE To evaluate the influence of high colloid oncotic pressure (COP) priming of cardiopulmonary bypass (CPB) on fluid balances, haemofiltration, capillary leakage and renal function in neonates and infants. METHODS Twenty neonates or infants underwent heart surgery using CPB and were randomised in two groups. For group 1 (FFP-group) a blood priming with fresh frozen plasma (FFP, low oncotic pressure) was chosen, for group 2 (HA-group) a blood priming containing FFP and human albumin 20% (HA) to realise higher oncotic pressures was substituted. All patients were monitored before, during and 6h after CPB. We measured weights, fluid balances, transfusion volumes, colloid oncotic pressures, inflammatory parameters (c-reactive protein, interleukin-6, interleukin-8, thrombocytes, leucocytes) and renal function (creatinine clearances, renal protein losses). RESULTS Patient's demographics and operational procedures were comparable in both groups with no further differences in operation procedures regarding palliation or correction. Colloid oncotic pressures of the priming solutions were higher in the HA-group (28 mmHg+/-4. 9) than in the FFP-group (6 mmHg+/-1. 3, p<0. 001). Relative weight gain as a marker of capillary leakage in the HA-group (2%+/-4. 5) was significantly lower 6h post CPB than in the FFP-group (8%+/-8. 0, p=0. 015). Haemofiltration rates were higher in the HA-group (569 ml+/-197 vs 282 ml+/-157, p=0. 002) on CPB. There were no differences of creatinine clearances 6h after the end of CPB. Renal protein losses were elevated in both groups without any inter-group differences during and 6h after CPB. CONCLUSION Addition of concentrated human albumin to priming fluids in paediatric cardiac surgery leads to less weight gain even after CPB. Supplementing paediatric patients undergoing cardiac surgery with concentrated human albumin does not affect renal function more severely than in paediatric patients undergoing cardiac surgery on CPB with blood priming.
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Fresh frozen plasma does not attenuate coagulation activation after neonatal cardiopulmonary bypass
Langstrom S, Rautiainen P, Mildh L, Peltola K, Wartiovaara-Kauto U, Heikinheimo M, Petaja J
ISTH Congress. 2007;: Abstract No. P-S-230.
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Fresh frozen plasma in the pediatric pump prime: a prospective, randomized trial
McCall MM, Blackwell MM, Smyre JT, Sistino JJ, Acsell JR, Dorman BH, Bradley SM
The Annals of Thoracic Surgery. 2004;77((3):):983-7; discussion 987.
Abstract
BACKGROUND The aim of this study was to determine whether the use of fresh frozen plasma (FFP) in the infant pump prime can avoid dilution of fibrinogen, decrease the need for blood product transfusion after bypass, and decrease exposure to donor blood products. METHODS Twenty infants weighing less than 8 kg were prospectively randomized to receive either 1 U of FFP (10 patients) or no FFP (10 patients) in the pump prime. Mean age (4. 2 +/- 2.8 months), weight (4.3 +/- 1.1 kg), total prime volume (641 +/- 96 ml), cardiopulmonary bypass time, cross-clamp time, lowest temperature on bypass, and preoperative coagulation parameters did not differ between the two groups. RESULTS At the end of bypass, the mean fibrinogen level was significantly higher in the FFP than the no FFP group (123 +/- 20 versus 58 +/- 17 mg/dL; p < 0. 0001), whereas the mean platelet count did not differ (60 +/- 25 versus 52 +/- 26 K/mm(3); p = 0.5). Patients in the FFP group received significantly fewer units of cryoprecipitate (0.4 +/- 0.8 versus 2.0 +/- 0.9 U/patient; p < 0.001), and had a mean total donor exposure of 4.1 +/- 1.5 U/patient versus 5.4 +/- 1.4 U/patient in the no FFP group (p = 0.06). The mean chest tube output over the first 24 hours did not differ between groups. CONCLUSIONS The use of FFP in the pump prime significantly limited dilutional hypofibrinogenemia, decreased the transfusion of cryoprecipitate after bypass, and tended to decrease the overall mean patient exposure to blood products.