Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Study

血液储存时间对生理测量的影响：RECESS 辅助研究

• 批准号: 8011715
• 负责人: ELLIOTT BENNETT-GUERRERO
• 金额: $ 38.94万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-07 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8011715
• 关键词: Acute; Address; Age; Ancillary Study; Blood; Blood flow; Boston; Cardiac; Cardiac Surgery procedures; Case Report Form; Cells; Cerebrum; Cessation of life; Clinical; Clinical Trials Network; Data; Data Base Management; Deterioration; Electronics; Enrollment; Erythrocyte Transfusion; Erythrocytes; Event; Functional disorder; Funding; Health; Hemostatic function; Hour; Image; Ischemia; Kidney; Laboratories; Lung; Measurement; Measures; Mechanical ventilation; Medicine; Methods; Microcirculation; Morbidity - disease rate; Near-Infrared Spectroscopy; New England; Observational Study; Operative Surgical Procedures; Organ; Outcome; Oxygen; Parents; Participant; Patients; Perfusion; Peripheral; Physiological; Postoperative Period; Randomized; Recovery; Research Institute; Retrospective Studies; Risk; Safety; Site; Skin; Surgical incisions; Techniques; Testing; Time; Tissue Viability; Tissues; Transfusion; Trauma; United States National Institutes of Health; Visually Impaired Persons; arm; cell bank; electronic data; experience; high risk; human study; medical schools; mortality; prospective; statistical service; tissue oxygenation

DESCRIPTION (provided by applicant): The desired impact of red blood cell (RBC) transfusion is to increase oxygen delivery as a means to protect tissues from ischemia. However, controversy exists over the safety and efficacy of transfusion with RBCs banked for short vs. long storage intervals. Although some retrospective studies in cardiac surgery patients have demonstrated associations between increased duration of RBC storage and increased mortality and morbidity, others have not detected any differences. No large, randomized prospective human study has attempted to correlate age of transfused RBCs with measures of end-organ dysfunction or death. PARENT STUDY: The REd CEll Storage Duration Study (RECESS) is being conducted by the NIH funded Transfusion Medicine and Hemostasis Clinical Trials Network. The primary objective is to determine if there are clinically important differences in outcomes and mortality in cardiac surgical patients (n=1,612) randomized to receive RBCs stored for shorter (d 10 days) vs. longer (e 21 days) periods of time. The impact of RBC storage on physiologic variables related to tissue oxygenation and the microcirculation has not been rigorously studied, nor have they been correlated with clinical outcomes. A few studies have investigated the effect of RBC transfusion on tissue oxygenation and the microcirculation. Of most relevance is a small study that demonstrated a deterioration in tissue oxygenation in trauma patients randomized to receive long storage RBCs but no change in those receiving short storage RBCs. PROPOSED ANCILLARY STUDY: Financial constraints limited us from pursuing the impact of storage duration on tissue oxygenation and the microcirculation in the parent trial. Our ancillary study proposes to obtain these additional measurements (e.g. peripheral and cerebral tissue oxygenation, and microvascular perfusion) at 4 study sites from a minimum of 250 participants in RECESS. Specific Aim: For optimal tissue viability, there must be adequate perfusion of the microcirculation and off-loading of oxygen by erythrocytes. We hypothesize that transfusion of RBCs stored for a longer time period decreases tissue oxygenation and microcirculatory perfusion compared with transfusion of RBCs stored for a shorter time period. This ancillary study will test this hypothesis by measuring tissue oxygenation (peripheral and cerebral) and microcirculatory perfusion following the transfusion of RBC that have been stored for shorter or longer periods of time in cardiac surgery patients enrolled in the RECESS trial. Raw electronic data will be obtained at 4 time points: prior to surgical incision, immediately prior to and after the unit of RBC transfusion in the ICU, and at 24 hours postoperatively. We will compare arms with respect to acute changes in these endpoints (change immediately prior to and after the administration of one unit of RBCs in the ICU) as well as less acute changes resulting from cumulative RBC units (change from prior to skin incision to 24 hours postoperatively). Raw data will be sent to an experienced core laboratory at Harvard Medical School, Boston, MA and will be analyzed by individuals blinded to study group assignment. PUBLIC HEALTH RELEVANCE: Red blood cells (RBCs) are transfused to patients with the aim of increasing oxygen delivery to tissues in order to protect them from ischemia. There are some studies which indicate that transfusion of RBCs stored for a longer period of time may harm cardiac surgical patients. However, there are also studies that show no difference. The proposed ancillary study will provide important new information on whether longer storage duration of RBCs has a negative impact on tissue oxygenation and blood flow at the level of the microcirculation.

描述(由申请人提供)： 输注红细胞(RBC)的预期效果是增加氧气输送，作为一种保护组织免受缺血的手段。然而，对于红血球储存时间短和储存时间长的安全性和有效性仍存在争议。虽然一些心脏手术患者的回顾性研究表明，红细胞储存时间的延长与死亡率和发病率的增加之间存在关联，但其他研究并未发现任何差异。没有一项大型的、随机的前瞻性人类研究试图将输血红细胞的年龄与终末器官功能障碍或死亡的指标联系起来。家长研究：由NIH资助的输血医学和止血临床试验网络正在进行红细胞储存持续时间研究(RESESESS)。主要目的是确定心脏外科患者(n=1,612)随机接受较短时间(d 10天)和较长时间(e 21天)的红细胞的结果和死亡率是否存在临床上的重要差异。红细胞储存对与组织氧合和微循环相关的生理变量的影响还没有得到严格的研究，也没有与临床结果相关的研究。少数研究探讨了红细胞输注对组织氧合和微循环的影响。最相关的是一项小型研究，该研究表明，随机接受长期储存红细胞的创伤患者组织氧合能力恶化，但接受短期储存红细胞的患者没有变化。拟议的辅助研究：财政限制限制了我们在母体试验中研究储存时间对组织氧合和微循环的影响。我们的辅助研究建议在4个研究地点从至少250名休息期的参与者那里获得这些额外的测量(例如，外周和脑组织氧合，以及微血管灌流)。具体目的：为了获得最佳的组织活力，必须有足够的微循环灌流和红细胞卸载氧。我们假设，与输注保存时间较短的红细胞相比，输注储存时间较长的红细胞会降低组织氧合和微循环灌注量。这项辅助研究将通过测量RBC输注后的组织氧合(外周和大脑)和微循环灌注量来验证这一假设，这些RBC在参加休息期试验的心脏手术患者中储存的时间较短或较长。原始电子数据将在4个时间点获得：手术切开前、ICU中RBC输注单元前、后即刻和术后24小时。我们将就这些终点的急性变化(在ICU中注射一单位红细胞之前和之后的变化)以及由于累积的红细胞单位引起的较小的变化(从切皮前到术后24小时的变化)来比较ARMS。原始数据将被发送到位于马萨诸塞州波士顿的哈佛医学院的经验丰富的核心实验室，并将由研究小组任务的盲人进行分析。与公共卫生相关：向患者输注红细胞(RBC)，目的是增加对组织的氧气输送，以保护他们免受缺血。有研究表明，输注储存时间较长的红细胞可能会对心脏手术患者造成伤害。然而，也有研究表明没有什么不同。这项拟议的辅助研究将提供重要的新信息，即较长的红细胞储存时间是否会在微循环水平上对组织氧合和血液流动产生负面影响。