Publications by authors named "Philip C Spinella"

The FDA recently licensed 14-day cold-stored platelets for bleeding patients. This policy change represents a reversal from the 1970s when cold-stored platelets were discontinued because of their short circulation time in healthy humans. This change will increase their availability in US hospitals with large trauma populations and in remote and rural settings in the U.

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Traumatic injury has the highest burden on morbidity and mortality in the United States. Early deaths from trauma are most frequently due to hemorrhage and could be prevented with more timely and efficacious treatments. A hallmark of trauma-induced coagulopathy (TIC) is hypofibrinogenemia, which is treated with fibrinogen concentrates (FibCon) or cryoprecipitate (Cryo).

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Background: There has been renewed interest in cold-stored platelets (CSPs) for the management of bleeding patients. CSPs might offer advantages over conventional room temperature stored platelet units (RTP), such as a lower risk of bacterial growth during storage, a longer shelf lf life, and possibly improved hemostatic effectiveness. However, CSPs have reduced in vivo survival compared to RTP.

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Introduction: Data regarding low titer group O whole blood (LTOWB) use for hemostatic resuscitation is largely derived from trauma cohorts; studies regarding its use in uninjured pediatric patients are lacking.

Methods: The blood bank database from a single academic pediatric hospital with a massive transfusion protocol (MTP) allowing the use of LTOWB for any severe bleeding etiology was queried between 2016 and 2023. Pediatric (age <18 years) recipients of LTOWB were included; injured children were excluded.

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Objectives: To characterize the epidemiology and management of massive bleeding events in children with cancer and/or hematopoietic cell transplant (HCT).

Design: Multicenter, retrospective cohort study.

Setting: Nineteen pediatric hospitals in Europe and United States.

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Background: Low-titer O whole blood (LTOWB) is commonly used in the United States for severe bleeding. Our objective was to examine disparities in LTOWB utilization and its association with survival.

Study Design And Methods: This retrospective analysis included patients receiving at least 1 L of red blood cells (RBC) or LTOWB in the first 4 h of admission.

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Hemorrhagic shock remains the leading cause of potentially preventable death among injured patients with life-threatening bleeding. Prehospital resuscitation has been evolving with increasing use of blood product resuscitation. The impact of blood administration on patient outcomes remains poorly defined with significant heterogeneity in the quality of literature supporting prehospital blood product resuscitation after trauma.

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Introduction: Life-threatening hemorrhage (LTH) is a significant cause of mortality in pediatrics. Timing of mortality in children with LTH is important for future trials.

Methods: In a secondary analysis of the prospective observational massive transfusion in children (MATIC) study, time-to-event analysis was performed to determine timing of death based on etiology of LTH and cause of death.

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Background: The Los Angeles Development and Rapid Operationalization of Prehospital Blood (LA-DROP) pilot will protocolize prehospital administration of low titer O-positive whole blood (LTO + WB) to patients with hemorrhagic shock in Los Angeles County (LAC). We sought to quantify the risk of death from hemolytic disease of the fetus and newborn (HDFN) associated with RhD-negative alloimmunization in females of childbearing potential (FCPs) as a result of LA-DROP.

Study Design And Methods: Retrospective data from LAC EMS databases were used in combination with estimates from published literature to assign probability distributions to each event in the sequence required for a transfusion of LTO + WB to result in a death from HDFN.

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Introduction: Traumatic brain injury (TBI) patients on antiplatelet therapy face higher mortality because of impaired platelet function, which may be treated by platelet transfusion. The value of testing platelet function in this cohort remains controversial. We aimed to evaluate the relationship between platelet function assays and outcomes in TBI patients on antiplatelet therapy receiving platelet transfusions.

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Objective: To determine the feasibility, efficacy, and safety of cold storage compared with room temperature (RT) platelet transfusion in patients with traumatic brain injury (TBI).

Background: Data demonstrating the safety and efficacy of cold-stored platelet (CSP) transfusion are lacking after TBI.

Methods: A phase 2, randomized, open-label clinical trial was performed at a single U.

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Background: Trauma-induced coagulopathy is common and associated with poor outcomes in injured children. Our aim was to identify patterns of coagulopathy after injury using endothelial, platelet, and coagulation biomarkers, and associate these phenotypes with relevant patient factors and clinical outcomes in a pediatric trauma cohort.

Methods: Principal component (PC) analysis was performed on data from injured children between 2018 and 2022.

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Article Synopsis
  • The study investigates the effectiveness of enoxaparin, a medication for preventing blood clots, in critically ill children, focusing on differences in response based on age, particularly between older children and infants.
  • It consists of two simultaneous clinical trials: one for older children aged 1-17 years, and another for infants under 1 year, with specific dosing protocols for each group.
  • The trials are set in multiple pediatric intensive care units across the U.S., using methods like randomization, ultrasonography, and blood analysis to assess outcomes and monitor safety.
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Background: Low titer group O whole blood (LTOWB) is commonly used for severe bleeding in trauma patients. LTOWB may also benefit young children requiring cardiac surgery with cardiopulmonary bypass (CPB) at risk of severe bleeding.

Study Design And Methods: In this retrospective study, children <2 years old who underwent cardiac surgery with CPB were included.

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Article Synopsis
  • - Whole blood (WB) resuscitation has been shown to be safer and potentially more effective than component therapy (CT) for trauma patients, particularly in pediatric cases, yet there is limited understanding of how the amount of WB given relates to patient outcomes.
  • - A study analyzed data from over 4,300 injured children to assess the impact of WB on mortality rates, revealing that WB transfusions significantly decreased the odds of death both at 4 hours (42% reduction) and at 24 hours (54% reduction) compared to those receiving only CT.
  • - The research also indicated that as the proportion of WB in total blood transfusion volume (WB/TTV ratio) increases, the likelihood of survival improves, with
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Trauma is the leading cause of death in individuals up to 45 years of age. Alterations in platelet function are a critical component of trauma-induced coagulopathy (TIC), yet these changes and the potential resulting dysfunction is incompletely understood. The lack of clinical assays available to explore platelet function in this patient population has hindered detailed understanding of the role of platelets in TIC.

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Objective: To determine the feasibility, efficacy, and safety of early cold stored platelet transfusion compared with standard care resuscitation in patients with hemorrhagic shock.

Background: Data demonstrating the safety and efficacy of early cold stored platelet transfusion are lacking following severe injury.

Methods: A phase 2, multicenter, randomized, open label, clinical trial was performed at 5 US trauma centers.

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Aims: The aim of this study is to describe the disposition of tranexamic acid (TXA) in adult trauma patients and derive a dosing regimen that optimizes exposure based on a predefined exposure target.

Methods: We performed a population pharmacokinetic (popPK) analysis of participants enrolled in the Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury (TAMPITI) trial (≥18 years with traumatic injury, given ≥1 blood product and/or requiring immediate transfer to the operating room) who were randomized to a single dose of either 2 or 4 g of TXA ≤2 h from time of injury. PopPK analysis was conducted using nonlinear mixed-effects modelling (NONMEM).

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Article Synopsis
  • A study investigated the effect of low titer group O whole blood (LTOWB) on survival rates in pediatric trauma patients, hypothesizing that a higher ratio of LTOWB to total blood product transfusions would improve survival outcomes.
  • Data from a pediatric trauma center covering 2015-2022 showed that 95 children who received LTOWB had a median age of 10 years, and a significant portion of their total transfusion volume was from LTOWB.
  • Results revealed that for every 10% increase in the LTOWB fraction of the total transfusion volume, in-hospital mortality decreased by 38%, highlighting the potential benefits of using LTOWB in traumatic resuscitation for children.
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Few data describe pediatric patients who receive massive transfusion for life-threatening hemorrhage (LTH) while on extracorporeal membrane oxygenation (ECMO). We present a retrospective secondary analysis of a multicenter prospective observational study to describe resource utilization and mortality in pediatric patients with LTH while on ECMO. Children who were on ECMO during an LTH were compared to children with LTH who were not on ECMO.

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Background: Admission hypocalcemia has been associated with poor outcomes in injured adults. The impact of hypocalcemia on mortality has not been widely studied in pediatric trauma.

Methods: A pediatric trauma center database was queried retrospectively (2013-2022) for children younger than 18 years who received blood transfusion within 24 hours of injury and had ionized calcium (iCal) level on admission.

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