Mechanism and Repository Study for the Red Cell Storage Duration Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 13
- 主要终点
- Comparison of pre- and post-operative lab values of vascular signaling, coagulation, microparticle counts, and inflammation and immune function
研究概览
简要总结
A large multicenter randomized controlled trial of approximately 1700 critically ill patients' status post complex cardiac surgery with sternotomy, called the Red Cell Storage Duration Study (RECESS), is currently ongoing. In the RECESS trial, study groups are randomized to either RBCs of less than or equal to 10 days storage time or to greater than or equal to 21 days. The primary outcome of RECESS is a change in multiple organ dysfunction score. Secondary outcomes in RECESS include all cause 28-day mortality, mechanical ventilation free days, and other clinical outcomes. The RECESS study presents a unique opportunity to investigate mechanisms associated with RBC storage duration in the context of clinical outcomes for well-characterized surgical study groups. The ancillary study described here is called the Mechanism and Repository Study (MARS) for RECESS.
The MARS study will analyze the most commonly reported and hypothesized mechanisms considered to be associated with the RBC storage lesion and adverse outcomes in critically ill patients. Laboratories with expertise in RBC function, nitric oxide mechanisms, the coagulation cascade, microparticle analysis and immunology will each examine hypotheses addressing mechanisms potentially able to relate storage time to clinical outcomes in RBC transfusion recipients. At the conclusion of the study, the results will provide a much better understanding of how RBC storage age affects recipient RBC function, coagulation parameters, microparticle load and immune modulation. Perhaps most importantly, this study will also develop a large sample repository for future analysis.
详细描述
MARS will enroll approximately 250 of the subjects participating in the RECESS study, and an additional 50 healthy volunteers. The RECESS subjects participating in MARS will have blood drawn before their cardiac surgery, and again 2 days after their cardiac surgery. If they have received any red blood cell (RBC) transfusions during their surgery or in the 96 hours following the end of their surgery, they will also have blood drawn at approximately 6 days, 28 days, and 180 days after their surgery, and will answer a health questionnaire at the 28-day and 180-day visits. The healthy volunteers participating in MARS will each have a single blood draw.
All MARS subjects will have blood samples sent to a repository for future study. A subset of the RECESS subjects participating in MARS, and all the healthy volunteers participating in MARS, will also have a number of laboratory tests performed as part of the MARS study. These tests will include
- laboratory measures of vascular signaling, including NO content, NO disposition; oxidative modification to RBC membrane thiols; and the flux in vasoactive S-nitrosothiols (RSNOs).
- laboratory measures of coagulation, including thrombin generation; prothrombin fragment 1+2, fibrinopeptide A; soluble thrombomodulin, protein C, PAI-1, tissue plasminogen activator, Factor V, Factor VII, Factor VIII, D-Dimer, antithrombin III, soluble endothelial protein C receptor, TFPI, Xia, INR, PT, and PTT (all using standard testing methods); and clot formation measured by rotation thrombo-elastometry.
- laboratory measures of microparticle counts, including CD3(T cells), CD66b(Granulocytes), CD 14(Monocytes), CD42a(Platelets), CD235a(RBCs), CD41a(Platelets), CD44(Surface glycoprotein), CD35(Complement receptor1), CD108(Semaphorin 7A), Annexin V, CD154(CD40-ligand), CD62p(p-selectin), CD59(Protectin), CD55(complement DAF), CD58(LFA-3).
- laboratory measures of inflammation and immune function, including regulatory T cells,Th17 cells, MMP-9, MPO, Pi-1 (total), sE-Selectin, sICAM-1, sVCAM-1, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-13, IFN-γ, GM-CSF, and TNF-α.
At one hospital, samples from RBC units transfused to MARS subjects will also be analyzed for nitric oxide parameters.
The primary objective of MARS is to compare post-operative values of these laboratory parameters between RBC-transfused RECESS subjects randomized to receive RBCs stored 10 days or less and RBC-transfused RECESS subjects randomized to receive RBCs stored 21 days or more.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of pre- and post-operative lab values of vascular signaling, coagulation, microparticle counts, and inflammation and immune function
时间窗: Day 2, 6, 28 and 180
The primary objective of MARS is to compare post-operative values of these laboratory parameters between RBC-transfused RECESS subjects randomized to receive RBCs stored 10 days or less and RBC-transfused RECESS subjects randomized to receive RBCs stored 21 days or more.
次要结局
未报告次要终点