Rahbar Elaheh, Cardenas Jessica C, Matijevic Nena, Del Junco Deborah, Podbielski Jeanette, Cohen Mitchell J, Cotton Bryan A, Holcomb John B, Wade Charles E
*Center for Translational Injury Research, Department of Surgery, University of Texas Health Science Center, Houston, Texas †Department of Biomedical Engineering, Wake Forest University, Winston-Salem, North Carolina ‡Department of Surgery, University of California San Francisco, San Francisco, California.
Shock. 2015 Nov;44(5):417-25. doi: 10.1097/SHK.0000000000000449.
The current study leveraged data from the Early Whole Blood (EWB) trial to explore the effects of modified whole blood (mWB) versus component (COMP) transfusions on coagulation parameters over time using longitudinal statistical methods.
The EWB study was a single-center randomized controlled trial, approved by the local IRB. Adult patients at highest-level trauma activations were randomized into mWB or COMP groups. Coagulation status was evaluated (at times 0, 3, 6, 12, and 24 h postadmission) using thrombelastography, platelet aggregometry, and calibrated automated thrombograms. Longitudinal statistical analyses with generalized estimating equations (GEE) were used to evaluate the effects of group, time, transfusion types, and their respective interactions on changes in measured coagulation markers.
A total of 59 patients were enrolled and adhered to protocol in the EWB trial, 25 in the mWB group, and 34 in the COMP group. Patients in both the mWB and COMP groups demonstrated a significant decline in their thrombelastography parameters during the first 3-6 h, specifically K-time, α-angle, maximum amplitude, G, and LY30. Patients receiving mWB exhibited improved thrombin potential than those receiving COMP. Platelet count and function declined over time in both mWB and COMP groups; however, platelet aggregation in response to ristocetin in the mWB group was significantly improved at 12 h compared with the COMP group. The longitudinal GEE model revealed significant group-time interactive effects on the changes in coagulation markers and significant effect of platelet transfusions on improvements in coagulation profile.
We observed significant interactive group-time effects, indicating that the types of transfusion as well as the time of transfusion significantly affect the patient's coagulation status. Our pilot data suggest that there is an improvement in platelet function with mWB, but further studies are needed. Regardless, platelet transfusions were associated with improvements in coagulation over time in both the groups.
本研究利用早期全血(EWB)试验的数据,采用纵向统计方法探讨改良全血(mWB)与成分血(COMP)输注随时间推移对凝血参数的影响。
EWB研究是一项由当地机构审查委员会批准的单中心随机对照试验。最高级创伤激活的成年患者被随机分为mWB组或COMP组。使用血栓弹力图、血小板聚集测定法和校准自动血栓图评估凝血状态(入院后0、3、6、12和24小时)。采用广义估计方程(GEE)进行纵向统计分析,以评估组、时间、输血类型及其各自的相互作用对测量的凝血标志物变化的影响。
EWB试验共纳入59例患者并遵守方案,mWB组25例,COMP组34例。mWB组和COMP组患者在最初3 - 6小时内血栓弹力图参数均显著下降,特别是K时间、α角、最大振幅、G和LY30。接受mWB的患者比接受COMP的患者表现出更好的凝血酶潜力。mWB组和COMP组的血小板计数和功能均随时间下降;然而,与COMP组相比,mWB组在12小时时对瑞斯托霉素的血小板聚集显著改善。纵向GEE模型显示,组 - 时间交互作用对凝血标志物变化有显著影响,血小板输注对改善凝血谱有显著作用。
我们观察到显著的组 - 时间交互作用,表明输血类型和输血时间均显著影响患者的凝血状态。我们的初步数据表明mWB可改善血小板功能,但仍需进一步研究。无论如何,两组患者血小板输注均与随时间推移的凝血改善相关。