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Postnatal intervention for the treatment of FNAIT: a systematic review
Baker JM, Shehata N, Bussel J, Murphy MF, Greinacher A, Bakchoul T, Massey E, Lieberman L, Landry D, Tanael S, et al
Journal of perinatology : official journal of the California Perinatal Association. 2019
Abstract
OBJECTIVE Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is associated with life-threatening bleeding. This systematic review of postnatal management of FNAIT examined transfusion of human platelet antigen (HPA) selected or unselected platelets, and/or IVIg on platelet increments, hemorrhage and mortality. STUDY DESIGN MEDLINE, EMBASE and Cochrane searches were conducted until 11 May 2018. RESULT Of 754 neonates, 382 received platelet transfusions (51%). HPA-selected platelets resulted in higher platelet increments and longer response times than HPA-unselected platelets. However, unselected platelets generally led to sufficient platelet increments to 30 x 10(9)/L, a level above which intracranial hemorrhage or other life-threatening bleeding rarely occurred. Platelet increments were not improved with the addition of IVIg to platelet transfusion. CONCLUSION Overall, HPA-selected platelet transfusions were more effective than HPA-unselected platelets but unselected platelets were often effective enough to achieve clinical goals. Available studies do not clearly demonstrate a benefit for addition of IVIg to platelet transfusion.
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2.
Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death
Fustolo-Gunnink SF, Fijnvandraat K, van Klaveren D, Stanworth S, Curley AE, Onland W, Steyerberg EW, de Kort E, d'Haens E, Hulzebos C, et al
Blood. 2019
Abstract
The Platelets for Neonatal Thrombocytopenia (PlaNeT-2) trial reported an unexpected overall benefit of a prophylactic platelet transfusion threshold of 25x109/L compared to 50x109/L for major bleeding and/or mortality in preterm neonates (7% absolute risk reduction). However, some neonates in the trial may have experienced little benefit or even harm from the 25x109/L threshold. We aimed to assess this heterogeneity of treatment effect in the PlaNet-2 trial, in order to investigate whether all preterm neonates benefit from the low threshold. We developed a multivariable logistic regression model in the PlaNet-2 data to predict baseline risk of major bleeding and/or mortality for all 653 neonates. We then ranked the neonates based on their predicted baseline risk and categorized them into four risk quartiles. Within these quartiles we assessed absolute risk difference between the 50x109/L and 25x109/L threshold group. A total of 146 neonates died or developed major bleeding. The internally validated C-statistic of the model was 0.63 (95% confidence interval 0.58 - 0.68). The 25x109/L threshold was associated with absolute risk reduction in all risk groups, varying from 4.9% in the lowest to 12.3% in the highest risk group. These results suggest that a 25x109/L prophylactic platelet count threshold can be adopted in all preterm neonates, irrespective of predicted baseline outcome risk. Future studies are needed to improve the predictive accuracy of the baseline risk model. Current Controlled Trials number ISRCTN87736839.
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3.
Platelet Transfusion for PDA Closure in Preterm Infants: A Randomized Controlled Trial
Kumar J, Dutta S, Sundaram V, Saini SS, Sharma RR, Varma N
Pediatrics. 2019
Abstract
BACKGROUND AND OBJECTIVES Thrombocytopenia is associated with late closure of patent ductus arteriosus (PDA). There are few studies evaluating platelet transfusions to treat PDA. We compared liberal platelet-transfusion criteria (to maintain a platelet count >100 000 per microL) versus standard criteria achieve earlier PDA closure among thrombocytopenic preterm neonates (<35 weeks' gestation) with hemodynamically significant PDA (hs-PDA) presenting within the first 2 weeks of life. METHODS Thrombocytopenic (<100 000 per microL) preterm neonates with hs-PDA were enrolled and randomly allocated to the liberal and standard transfusion groups: 22 in each arm. They underwent echocardiography daily until closure of PDA, completion of 120 hours follow-up, or death. All subjects received standard cotreatment with nonsteroidal antiinflammatory drugs. Primary outcome of time to PDA closure was compared by survival analysis. Multivariate Cox proportional hazard regression was performed with randomization group, baseline platelet count, gestational age, and age at enrollment as predictor variables. RESULTS Median time to PDA closure was 72 (95% confidence interval [CI] 55.9-88.1) versus 72 (95% CI 45.5-98.4) hours in the liberal versus restrictive transfusion groups, respectively (unadjusted hazard ratio 0.88 [95% CI 0.4-1.9]; P = .697). Despite adjusting for potential confounders, there was no significant difference in time to PDA closure. In the liberal transfusion group, 41% of infants had any grade of intraventricular hemorrhage compared with 4.5% in the restrictive group (P = .009). CONCLUSIONS Attempting to maintain a platelet count >100 000 per microL by liberally transfusing platelets in preterm thrombocytopenic neonates with hs-PDA does not hasten PDA closure.
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4.
Platelets for neonatal transfusion - study 2: a randomised controlled trial to compare two different platelet count thresholds for prophylactic platelet transfusion to preterm neonates
Curley A, Venkatesh V, Stanworth S, Clarke P, Watts T, New H, Willoughby K, Khan R, Muthukumar P, Deary A
Neonatology. 2014;106((2):):102-6.
Abstract
INTRODUCTION Neonatal thrombocytopenia is a common and important clinical problem in preterm neonates. A trial assessing clinically relevant outcomes in relation to the different platelet count thresholds used to trigger transfusion has never been undertaken in preterm neonates with severe thrombocytopenia. OBJECTIVES Platelets for Neonatal Transfusion - Study 2 (PlaNeT-2) aims to assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in current standard practice in reducing the proportion of patients who have a major bleed or die up to study day 28. METHODS PlaNeT-2 is a two-stage, randomised, parallel-group, superiority trial. PlaNet-2 compares clinical outcomes in preterm neonates (<34 weeks' gestation at birth) randomised to receive prophylactic platelet transfusions to maintain platelet counts at or above either 25 x 10(9)/l or 50 x 10(9)/l. The primary outcome measure is the proportion of patients who either die or experience a major bleed up to and including study day 28. A total of 660 infants will be randomised. RESULTS AND CONCLUSIONS This trial will help define optimal platelet transfusion support for severely thrombocytopenic preterm neonates by evaluating the risks and benefits of two different prophylactic neonatal platelet transfusion thresholds. 2014 S. Karger AG, Basel.
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5.
A no-prophylaxis platelet-transfusion strategy for hematologic cancers
Stanworth SJ, Estcourt LJ, Powter G, Kahan BC, Dyer C, Choo L, Bakrania L, Llewelyn C, Littlewood T, Soutar R, et al
New England Journal of Medicine. 2013;368((19):):1771-80.
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Abstract
BACKGROUND The effectiveness of platelet transfusions to prevent bleeding in patients with hematologic cancers remains unclear. This trial assessed whether a policy of not giving prophylactic platelet transfusions was as effective and safe as a policy of providing prophylaxis. METHODS We conducted this randomized, open-label, noninferiority trial at 14 centers in the United Kingdom and Australia. Patients were randomly assigned to receive, or not to receive, prophylactic platelet transfusions when morning platelet counts were less than 10x10(9) per liter. Eligible patients were persons 16 years of age or older who were receiving chemotherapy or undergoing stem-cell transplantation and who had or were expected to have thrombocytopenia. The primary end point was bleeding of World Health Organization (WHO) grade 2, 3, or 4 up to 30 days after randomization. RESULTS A total of 600 patients (301 in the no-prophylaxis group and 299 in the prophylaxis group) underwent randomization between 2006 and 2011. Bleeding of WHO grade 2, 3, or 4 occurred in 151 of 300 patients (50%) in the no-prophylaxis group, as compared with 128 of 298 (43%) in the prophylaxis group (adjusted difference in proportions, 8.4 percentage points; 90% confidence interval, 1.7 to 15.2; P=0.06 for noninferiority). Patients in the no-prophylaxis group had more days with bleeding and a shorter time to the first bleeding episode than did patients in the prophylaxis group. Platelet use was markedly reduced in the no-prophylaxis group. A prespecified subgroup analysis identified similar rates of bleeding in the two study groups among patients undergoing autologous stem-cell transplantation. CONCLUSIONS The results of our study support the need for the continued use of prophylaxis with platelet transfusion and show the benefit of such prophylaxis for reducing bleeding, as compared with no prophylaxis. A significant number of patients had bleeding despite prophylaxis. (Funded by the National Health Service Blood and Transplant Research and Development Committee and the Australian Red Cross Blood Service; TOPPS Controlled-Trials.com number, ISRCTN08758735.).
PICO Summary
Population
Patients 16 years old or older, with hematologic cancers enrolled at 14 centres in the United Kingdom and Australia (n= 600).
Intervention
Prophylactic platelet transfusions (Prophylaxis group, n= 299).
Comparison
No prophylactic platelet transfusions (No-prophylaxis group, n= 301).
Outcome
Bleeding of WHO grade 2, 3, or 4 occurred in 151 of 300 patients (50%) in the no-prophylaxis group, as compared with 128 of 298 (43%) in the prophylaxis group (adjusted difference in proportions, 8.4 percentage points; 90% confidence interval, 1.7 to 15.2). Patients in the no-prophylaxis group had more days with bleeding and a shorter time to the first bleeding episode than did patients in the prophylaxis group. Platelet use was markedly reduced in the no-prophylaxis group. A prespecified subgroup analysis identified similar rates of bleeding in the two study groups among patients undergoing autologous stem-cell transplantation.
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Bleeding risks are higher in children versus adults given prophylactic platelet transfusions for treatment-induced hypoproliferative thrombocytopenia
Josephson CD, Granger S, Assmann SF, Castillejo MI, Strauss RG, Slichter SJ, Steiner ME, Journeycake JM, Thornburg CD, Bussel J, et al
Blood. 2012;120((4):):748-60.
Abstract
Age-group analyses were conducted of patients in the prophylactic platelet dose trial (PLADO), which evaluated the relation between platelet dose per transfusion and bleeding. Hospitalized patients with treatment-induced hypoproliferative thrombocytopenia were randomly assigned to 1 of 3 platelet doses: 1.1 × 10 (11), 2.2 × 10 (11), or 4.4 × 10 (11) platelets/m (2) per transfusion, given for morning counts of <= 10 000 platelets/µL. Daily hemostatic assessments were performed. The primary end point (percentage of patients who developed grade 2 or higher World Health Organization bleeding) was evaluated in 198 children (0-18 years) and 1044 adults. Although platelet dose did not predict bleeding for any age group, children overall had a significantly higher risk of grade 2 or higher bleeding than adults (86%, 88%, 77% vs 67% of patients aged 0-5 years, 6-12 years, 13-18 years, vs adults, respectively) and more days with grade 2 or higher bleeding (median, 3 days in each pediatric group vs 1 day in adults; P < .001). The effect of age on bleeding differed by disease treatment category and was most pronounced among autologous transplant recipients. Pediatric subjects were at higher risk of bleeding over a wide range of platelet counts, indicating that their excess bleeding risk may be because of factors other than platelet counts.
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Discontinuing prophylactic transfusions increases the risk of silent brain infarction in children with sickle cell disease: data from STOP II
Abboud MR, Yim E, Musallam KM, Adams RJ
Blood. 2011;118((4):):894-8.
Abstract
In the STOP II trial, discontinuation of prophylactic transfusions in high risk children with sickle cell disease (SCD) resulted in a high rate of reversion to abnormal blood-flow velocities on transcranial Doppler (TCD) ultrasonography and strokes. We analyzed data from STOP II to determine the effect of discontinuing transfusions on the development or progression of silent brain infarcts on magnetic resonance imaging (MRI). At study entry, 21 of 79 (27%) patients had evidence of silent infarcts. There were no statistically significant differences in baseline characteristics between patients with normal brain MRI or silent infarcts at study entry. At study end, 3 of 37 (8.1%) patients in the continued-transfusion group developed new brain MRI lesions compared with 11 of 40 (27.5%) in the transfusion-halted group (P = .03). The total number of lesions remained essentially unchanged decreasing from 25 to 24 in the continued-transfusion group while increasing from 27 to 45 in transfusion-halted patients. Thus, discontinuation of transfusions in children with SCD and abnormal TCD who revert to low-risk increases the risk of silent brain infarction. Together with data from STOP, these findings demonstrate that transfusions prevent the development of silent infarcts in patients with SCD and abnormal TCD but normal MRA.
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Thrombopoietin following transfusion of platelets in preterm neonates
Kline A, Mackley A, Taylor SM, McKenzie SE, Paul DA
Platelets. 2008;19((6):):428-31.
Abstract
Thrombocytopenia is common in the neonatal intensive care unit. Transfusion of platelets is often required. The purpose of our study was to determine changes in thrombopoietin (Tpo) following transfusion of platelets in preterm neonates. Preterm neonates undergoing platelet transfusion were randomized to receive a transfusion volume of either 10 or 15 ml/kg. Blood was obtained for Tpo measurement pre-transfusion, one and 24 hours post-transfusion. Platelet Factor 4 (PF4) was also measured to quantify platelet activation. Statistical analysis was performed using repeated measures ANOVA, and Mann-Whitney U test as appropriate. Ten infants were enrolled in each group. Gestational age, birth weight, etiology of thrombocytopenia, and timing of transfusion did not differ between the 10 and 15 ml/kg groups. There were no differences between the groups in platelet count prior to and/or following transfusion. Both transfusion volumes were equally well tolerated. Tpo and PF4 did not differ between groups at any of the study time points. When both groups were analysed together, Tpo dropped 43% (95% confidence 37-49%, p = 0. 01) 1-hour post compared to pre-transfusion. In conclusion the observed decrease in Tpo following platelet transfusion suggests that Tpo kinetics in neonates is similar to adults following transfusion. PF4 was not affected by transfusion. There was not an increase in platelet count following transfusion volume of 15 ml/kg compared to 10 ml/kg.
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Platelet transfusions in children: results of a randomized, prospective, crossover trial of plasma removal and a prospective audit of WBC reduction
Couban S, Carruthers J, Andreou P, Klama LN, Barr R, Kelton JG, Heddle NM
Transfusion. 2002;42((6):):753-8.
Abstract
BACKGROUND Febrile nonhemolytic transfusion reactions (FNHTRs) complicate 2 to 37 percent of platelet transfusions in adults, but the incidence of such reactions in children is not known. The effectiveness of plasma reduction after storage and WBC reduction of platelet concentrates before storage was studied in pediatric recipients of platelet transfusions. STUDY DESIGN AND METHODS In the first study, a prospective randomized crossover design was used in which patients received either unmodified whole-blood-derived or apheresis platelets or platelets from which most of the plasma supernatant had been removed just before transfusion. The second study was a prospective audit of recipients of prestorage WBC-reduced platelets. Children between 3 months and 17 years of age were eligible for both studies. Patients were assessed for signs and symptoms that are characteristic of a reaction during, immediately after, and 2 hours following transfusion. RESULTS There were 226 platelet transfusions administered to 66 children. One hundred and sixty transfusions were given to 35 children enrolled in the randomized study, and 66 transfusions were given to 33 children during the audit. In the randomized study, nine of the 75 transfusions of unmodified platelets (12%) and six of 85 transfusions of poststorage plasma-removed platelets (7%) were associated with an FNHTR (p=0.42). In the audit, three of 66 transfusions of prestorage WBC-reduced platelets (5%) were associated with an FNHTR. Allergic reactions occurred with 5 percent (4 of 75), 6 percent (5 of 85), and 6 percent (4 of 66) of platelet transfusions, respectively. CONCLUSION FNHTRs appear to be less common among pediatric recipients of platelet transfusions than in adults. In our two studies, there was a trend toward a lower frequency of FNHTRs with poststorage plasma removal and prestorage WBC reduction than with standard platelets, but this was not significant.
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A randomized, controlled trial of platelet transfusions in thrombocytopenic premature infants
http:, www.jpeds.com/article/S-347681705-6/abstractAndrew M, Vegh P, Caco C, Kirpalani H, Jefferies A, Ohlsson A, Watts J, Saigal S, Milner R, et al
Journal of Pediatrics. 1993;123((2):):285-91.
Abstract
A multicenter prospective, randomized controlled trial was conducted to determine whether early use of platelet concentrates would reduce the incidence or extension of intracranial hemorrhage or both in sick preterm infants with thrombocytopenia. The effects on bleeding as reflected by the amount of blood product support administered and a shortened bleeding time were assessed as secondary outcomes. Premature infants with a platelet count < 150 x 10(9)/L within the first 72 hours of life were randomly assigned to receive either conventional therapy or conventional therapy plus platelet concentrates (10 ml/kg). The platelet count was maintained < 150 x 10(9)/L until day 7 of life by one to three platelet transfusions. In 22 (28%) of the 78 treated infants and 19 (26%) of the 74 control infants, either a new intracranial hemorrhage developed or an already-present one became more extensive (p = 0.73). Similar numbers of infants had each grade of intracranial hemorrhage on both initial and follow-up ultrasonography. Similar numbers of infants received fresh frozen plasma and packed red blood cells, but treated infants received less of both. The bleeding time was prolonged in the treated group before the infusion of platelet concentrates but subsequently shortened (mean difference, 79.0; 95% confidence interval, 73.1 to 84.9). Subanalysis of the control group showed that infants with platelet counts < 60 x 10(9)/L (n = 21) on at least one occasion received more fresh frozen plasma and packed red blood cells than did those with platelet counts > 60 x 10(9)/L.(ABSTRACT TRUNCATED AT 250 WORDS)