Background This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature–stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials. Methods A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery. In stage I, a two-armed randomized trial, platelets stored up to 7 days in the cold were compared with those stored at room temperature. In the subsequent single-arm stage II, cold storage time was extended to 8 to 14 days. The primary outcome was clinical effect measured by chest drain output. Secondary outcomes were platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality. Results In stage I, the median chest drain output was 720 ml (quartiles 485 to 1,170, n = 25) in patients transfused with room temperature–stored platelets and 645 ml (quartiles 460 to 800, n = 25) in patients transfused with cold-stored platelets. No significant difference was observed. The difference in medians between the room temperature– and cold-stored up to 7 days arm was 75 ml (95% CI, −220, 425). In stage II, the median chest drain output was 690 ml (500 to 1,880, n = 15). The difference in medians between the room temperature arm and the nonconcurrent cold-stored 8 to 14 days arm was 30 ml (95% CI, −1,040, 355). Platelet aggregation in vitro increased after transfusion in both the room temperature– and cold-stored platelet study arms. Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature–stored platelets. Conclusions This pilot trial supports the feasibility of platelets stored cold for up to 14 days and provides critical guidance for future pivotal trials in high-risk cardiothoracic bleeding patients. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New
Hemorrhagic shock is both a local and systemic disorder. In the context of systemic effects, blood loss may lead to levels of reduced oxygen delivery (DO2) sufficient to cause tissue ischemia. Similar to other physiologic debts such as sleep, it is not possible to incur a significant oxygen debt and suffer no consequences for lack of timely repayment. While the linkage between oxygen debt and traditional organ failure (renal, hepatic, lung, and circulation) has been long recognized, we should consider failure in two additional linked and very dynamic organ systems, the endothelium and blood. These systems are very sensitive to oxygen debt and at risk for failing, having further implications on all other organ systems. The degree of damage to the endothelium is largely modulated by the degree of oxygen debt. Thus hypoperfusion is believed to begin a cascade of events leading to acute traumatic coagulopathy (ATC). This combination of oxygen debt driven endothelial damage and ATC might be considered collectively as “blood failure” due to the highly connected networks between these drivers. This article presents the implications of oxygen debt for remote damage control resuscitation strategies, such as permissive hypotension and hemostatic resuscitation. We review the impact of whole blood resuscitation and red blood cell efficacy in mitigation of oxygen debt. At last, this article recognizes the need for simple and durable, lightweight equipment that can detect the adequacy of tissue DO2 and thus patient needs for resuscitative care. Point‐of‐care lactate measuring may be a predictive tool for identifying high‐risk trauma patients and occult shock because it provides information beyond that of vital signs and mechanism of injury as it may help predict the level of oxygen debt accumulation and need for resuscitation. Serial measurements may also be valuable as a tool in guiding resuscitative efforts.
The Trauma Hemostasis and Oxygenation Research (THOR) Network has developed a consensus statement on the role of permissive hypotension in remote damage control resuscitation (RDCR). A summary of the evidence on permissive hypotension follows the THOR Network position on the topic. In RDCR, the burden of time in the care of the patients suffering from noncompressible hemorrhage affects outcomes. Despite the lack of published evidence, and based on clinical experience and expertise, it is the THOR Network's opinion that the increase in prehospital time leads to an increased burden of shock, which poses a greater risk to the patient than the risk of rebleeding due to slightly increased blood pressure, especially when blood products are available as part of prehospital resuscitation.The THOR Network's consensus statement is, "In a casualty with life-threatening hemorrhage, shock should be reversed as soon as possible using a blood-based HR fluid. Whole blood is preferred to blood components. As a part of this HR, the initial systolic blood pressure target should be 100 mm Hg. In RDCR, it is vital for higher echelon care providers to receive a casualty with sufficient physiologic reserve to survive definitive surgical hemostasis and aggressive resuscitation. The combined use of blood-based resuscitation and limiting systolic blood pressure is believed to be effective in promoting hemostasis and reversing shock".
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