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Platelet Transfusion before CVC Placement in Patients with Thrombocytopenia
van Baarle FLF, van de Weerdt EK, van der Velden Wjfm, Ruiterkamp RA, Tuinman PR, Ypma PF, van den Bergh WM, Demandt AMP, Kerver ED, Jansen AJG, et al
The New England journal of medicine. 2023;388(21):1956-1965
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Editor's Choice
Abstract
BACKGROUND Transfusion guidelines regarding platelet-count thresholds before the placement of a central venous catheter (CVC) offer conflicting recommendations because of a lack of good-quality evidence. The routine use of ultrasound guidance has decreased CVC-related bleeding complications. METHODS In a multicenter, randomized, controlled, noninferiority trial, we randomly assigned patients with severe thrombocytopenia (platelet count, 10,000 to 50,000 per cubic millimeter) who were being treated on the hematology ward or in the intensive care unit to receive either one unit of prophylactic platelet transfusion or no platelet transfusion before ultrasound-guided CVC placement. The primary outcome was catheter-related bleeding of grade 2 to 4; a key secondary outcome was grade 3 or 4 bleeding. The noninferiority margin was an upper boundary of the 90% confidence interval of 3.5 for the relative risk. RESULTS We included 373 episodes of CVC placement involving 338 patients in the per-protocol primary analysis. Catheter-related bleeding of grade 2 to 4 occurred in 9 of 188 patients (4.8%) in the transfusion group and in 22 of 185 patients (11.9%) in the no-transfusion group (relative risk, 2.45; 90% confidence interval [CI], 1.27 to 4.70). Catheter-related bleeding of grade 3 or 4 occurred in 4 of 188 patients (2.1%) in the transfusion group and in 9 of 185 patients (4.9%) in the no-transfusion group (relative risk, 2.43; 95% CI, 0.75 to 7.93). A total of 15 adverse events were observed; of these events, 13 (all grade 3 catheter-related bleeding [4 in the transfusion group and 9 in the no-transfusion group]) were categorized as serious. The net savings of withholding prophylactic platelet transfusion before CVC placement was $410 per catheter placement. CONCLUSIONS The withholding of prophylactic platelet transfusion before CVC placement in patients with a platelet count of 10,000 to 50,000 per cubic millimeter did not meet the predefined margin for noninferiority and resulted in more CVC-related bleeding events than prophylactic platelet transfusion. (Funded by ZonMw; PACER Dutch Trial Register number, NL5534.).
PICO Summary
Population
Patients with severe thrombocytopenia enrolled in the PACER randomised controlled trial (n= 338).
Intervention
Placement of a central venous catheter (CVC) with one unit of prophylactic platelet transfusion (188 placements).
Comparison
Placement of an CVC without a platelet transfusion (185 placements).
Outcome
A total of 373 episodes of CVC placement involving 338 patients were included in the per-protocol primary analysis. Catheter-related bleeding of grade 2 to 4 occurred in 9 of 188 patients (4.8%) in the transfusion group and in 22 of 185 patients (11.9%) in the no-transfusion group (relative risk, 2.45; 90% confidence interval (CI), [1.27, 4.70]). Catheter-related bleeding of grade 3 or 4 occurred in 4 of 188 patients (2.1%) in the transfusion group and in 9 of 185 patients (4.9%) in the no-transfusion group (relative risk, 2.43; 95% CI [0.75, 7.93]). There were 15 adverse events, of these events 13 (all grade 3 catheter-related bleeding [4 in the transfusion group and 9 in the no-transfusion group]) were categorized as serious. The net savings of withholding prophylactic platelet transfusion before CVC placement was $410 per catheter placement.
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2.
A randomized cross-over study of cryopreserved platelets in prophylactic transfusions of thrombocytopenic patients
Ang, A. L., Gan, L. S. H., Tuy, T. T., Ang, C. H., Tan, C. W., Tan, H. H., Shu, P. H., Zhang, Q., Cao, Y., Moorakonda, R. B., et al
Transfusion. 2023
Abstract
BACKGROUND The short shelf-life of liquid-stored platelets (LP) at 20-24°C poses shortage and wastage challenges. Cryopreserved platelets have significantly extended shelf-life, and were safe and efficacious for therapeutic transfusions of bleeding patients in the Afghanistan conflict and phase 2 randomized studies. Although hematology patients account for half of platelets demand, there is no randomized study on prophylactic cryopreserved platelet transfusions in them. METHODS We performed a phase 1b/2a randomized cross-over study comparing the safety and efficacy of cryopreserved buffy coat-derived pooled platelets (CP) to LP in the prophylactic transfusions of thrombocytopenic hematology patients. RESULTS A total of 18 adults were randomly assigned 1:1 to CP and LP for their first thrombocytopenic period (TP) of up to 28-days. A total of 14 crossed over to the other platelet-arm for the second TP. Overall, 17 subjects received 51 CP and 15 received 52 LP. CP-arm had more treatment emergent adverse event (29.4% vs. 13.3% of subjects, 9.8% vs. 3.8% of transfusions) than LP-arm but all were mild. No thromboembolism was observed. Both arms had similar bleeding rates (23.5% vs. 26.7% of subjects) which were all mild. Subjects in CP-arm had lower average corrected count increments than LP-arm (mean [SD] 5.6 [4.20] vs. 22.6 [9.68] ×10(9) /L at 1-4 h, p < .001; 5.3 [4.84] vs. 18.2 [9.52] ×10(9) /L at 18-30 h, p < .001). All TEG parameters at 1-4 h and maximum amplitude (MA) at 18-30 h improved from baseline post-CP transfusion (p < .05) though improvements in K-time and MA were lower than LP (p < .05). DISCUSSION During shortages, CP may supplement LP in prophylactic transfusions of thrombocytopenic patients.
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The impact of pathogen-reduced platelets in acute leukaemia treatment on the total blood product requirement: a subgroup analysis of an EFFIPAP randomised trial
Garban F, Vilotitch A, Tiberghien P, Bosson JL
Transfusion medicine (Oxford, England). 2022
Abstract
OBJECTIVE To evaluate the impact of pathogen-reduced (PR) platelet transfusions on blood products requirement for clinical practice. BACKGROUND PR platelets are increasing in use as standard blood products. However, few randomised trials have evaluated their impact on bleeding control or prevention. Furthermore, PR platelets recirculate less than untreated platelets. METHODS A subgroup study of the randomised clinical trial EFFIPAP compared three arms of platelet preparations (PR: P-PRP/PAS, additive solution: P-PAS and plasma P-P arms respectively). The subgroup of acute leukaemia patients, in their chemotherapy induction phase, included 392 patients (133 P-PRP/PAS arm, 132 P-PAS arm and 130 P-P arm). Blood requirements were analysed across over periods of 7 days. RESULTS The number of platelet transfusions per week was significantly higher in the P-PRP/PAS group 2.3 [1.6-3.3] compared to the control groups 1.9 [1.3-2.8] and 2.0 [1.3-3.0] for P-P and P-PAS groups respectively (p < 0.0001). However, the total number of platelets transfused per week was not different. The number of red blood cell concentrates (RBC) transfusion per week did not differ either. CONCLUSION In a homogeneous group of patients, platelet pathogen reduction resulted in an increased number of platelet units transfused per week while having no impact on the total number of platelets transfused or the number of RBC transfusion; resulting to an average requirement of 2 RBC and 2-3 platelets transfusions per week of marrow aplasia.
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4.
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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5.
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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6.
The effect of variation in donor platelet function on transfusion outcome: a semi-randomised controlled trial
Kelly AM, Garner SF, Foukaneli T, Godec TR, Herbert N, Kahan BC, Deary A, Bakrania L, Llewelyn C, Ouwehand WH, et al
Blood. 2017;130((2):):214-220
Abstract
The effect of variation in platelet function in platelet donors on patient outcome following platelet transfusion is unknown. This trial assessed the hypothesis that platelets collected from donors with highly responsive platelets to agonists in vitro assessed by flow cytometry (high responder donors), are cleared more quickly from the circulation than those from low responder donors, resulting in lower platelet count increments following transfusion. This parallel group, semi-randomised double-blinded trial was conducted in a single UK centre. Eligible patients were those 16 or older with thrombocytopenia secondary to bone marrow failure, requiring prophylactic platelet transfusion. Patients were randomly assigned to receive a platelet donation from a high or low responder donor when both were available, or when only one type of platelet was available patients received that. Participants, investigators and those assessing outcomes were masked to group assignment. The primary endpoint was the platelet count increment 10-90 minutes following transfusion. Analysis was by intention-to-treat. Fifty one patients were assigned to receive platelets from low responder donors, and 49 from high responder donors (47 of which were randomised and 53 non-randomised). There was no significant difference in platelet count increment 10-90 minutes following transfusion in patients receiving platelets from high (mean 21.0 x109/L, 95% CI 4.9 to 37.2) or low (mean 23.3x109/L, 95% CI 7.8 to 38.9) responder donors (mean difference 2.3, 95%CI -1.1 to 5.7, p = 0.18). These results support the current policy of not selecting platelet donors on the basis of platelet function for prophylactic platelet transfusion.
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7.
Application of HLAMatchmaker computer programme to select HLA epitope matched platelets for alloimmunised thrombocytopenic patients with aplastic anaemia, MDS and acute myeloid leukaemia
Marsh JCW, Kallon D, Brown C, Pigden C, Deary A, Harding K, Choo L, LLewelyn C, Mijovic A, Mufti GJ, et al
British Journal of Haematology. 2014;165((S1):):95.. Abstract No. 228.
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8.
Post-transfusion increment of platelet count in thrombocytopenic patients treated with platelet concentrates
Hoque MM, Rahman M, Rahman SM, Habibullah MM, Faruki MA, Rahman KH, Mamun AA, Hossain MA
Mymensingh Medical Journal: MMJ. 2013;22((1):):64-8.
Abstract
The Platelet (PLT) Transfusion Therapy plays an important role in the support of surgical, haematological, oncological and transplant patients. The present study was assigned to find out the post transfusion increment of platelet count among the thrombocytopenic patients in Bangladeshi population. This descriptive study was conducted at the Departments of Haematology and Transfusion Medicine, BSMMU, Dhaka. Total 42 thrmbocytopenic patients were randomly assigned to receive a transfusion when their platelet counts below 10000 per cubic millimeter or with active bleeding. Pre transfusion and post transfusion platelet count were measured in all patients. Out of 42 patients, 26(61.90%) were male and 16(38.10%) were female. Leukemia was the most common cause of thrombocytopenia (47.62%). Most of the patients (71.34%) required transfusion of multiple units of platelet and 12(28.57%) patients required double units. Before transfusion of platelet concentrate <30x108/L, 30-80x108/L and >80x108/L platelet count were found in 30(71.43%), 08(19.05%) and 04(09.52%) patients respectively. After transfusion of platelet concentrate <50x108/L, 50-100x108/L and >100x108/L platelet count were found in 30(71.43%), 08(19.05%) and 04(09.52%) patients respectively. In all patients post transfusion platelet count increases but 2 or multiple units of transfusion were needed.
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9.
TEG as a surrogate marker for the haemostatic function of PRT treated platelets in thrombocytopenic patients
Johansson PI, Simonsen A, Ostrowski SR, Deberdt L, Marschner S, Goodrich R
Transfusion. 2012;52((S3):):67A.. Abstract No. SP34.
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10.
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.