Fibrinogen Measurements in Plasma and Whole Blood: A Performance Evaluation Study of the Dry-Hematology System
Fibrinogen Measurements in Plasma and Whole Blood: A Performance Evaluation Study of the Dry-Hematology System
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DOI：
10.1213/ane.0000000000000448
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发表时间：
2015-01-01
影响因子：
5.7
通讯作者：
Mizobe, Toshiki
中科院分区：
文献类型：
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作者：
Ogawa, Satoru;Tanaka, Kenichi A.;Mizobe, Toshiki
背景：在出血过程中，准确快速测定纤维蛋白原水平对于建立及时的止血干预非常重要。纤维蛋白原测量的准确性可能受到其测定的特定方法、液体治疗和抗凝剂的影响。干式血液学方法（DRIHEMATO（R））是一种基于凝血酶活化凝血时间测定血浆和全血中纤维蛋白原水平的新方法。我们假设，血浆或全血纤维蛋白原水平使用干血液学方法将与传统的血浆纤维蛋白原assays.METHODS：获得性低纤维蛋白原血症进行建模，从12名健康志愿者获得的血液样品的系列稀释。用生理盐水、5%人血白蛋白或6%羟乙基淀粉稀释柠檬酸盐全血样本，以实现25%、50%和75%的容量置换。在血浆或全血样本中比较了干血液学方法、Clauss方法、凝血酶原时间（PT）衍生方法、抗原水平测定和血栓弹性纤维蛋白形成。检查肝素对各试验的影响（0 - 6 IU/mL）。结果：在血浆样本中，干血法与Clauss法无显著性差异，而干血法的纤维蛋白原水平低于PT法和抗原水平法。干式血液学方法与Clauss方法、PT衍生方法和纤维蛋白原抗原水平的一致性相关系数（Pc）可接受（Pc = 0.91-0.99）。稀释剂和肝素的类型影响PT衍生方法和血栓弹性测定法的结果，但不影响干血液学方法。在心脏手术患者中，干血液学和其他方法之间的纤维蛋白原水平的总体相关性与体外稀释实验的结果相当。干血液学报告全血中的纤维蛋白原值高于血浆样本中的纤维蛋白原值，但红细胞压积调整降低了全血和血浆样本之间的偏倚，从73 mg/dL（95%预测区间：40，106）至-13 mg/dL（95%预测区间：-35，8.5）。这项研究表明，纤维蛋白原水平可以准确地评估干-血浆中的血液学方法，结果不受肝素或胶体的影响。对于通过干血液学进行的全血纤维蛋白原测量，有必要进行红细胞压积调整，以补偿围手术期出血情况下红细胞压积的动态变化。
BACKGROUND: An accurate and rapid determination of fibrinogen level is important during hemorrhage to establish a timely hemostatic intervention. The accuracy of fibrinogen measurements may be affected by the specific methodology for its determination, fluid therapies, and anticoagulant agents. The dry-hematology method (DRIHEMATO (R)) is a novel approach to determine fibrinogen levels in plasma and whole blood based on thrombin-activated coagulation time. We hypothesized that plasma or whole blood fibrinogen level using the dry-hematology method would be similar to those measured with conventional plasma fibrinogen assays.METHODS: Acquired hypofibrinogenemia was modeled by serial dilutions of blood samples obtained from 12 healthy volunteers. Citrated whole blood samples were diluted with either normal saline, 5% human albumin, or 6% hydroxyethyl starch to achieve 25%, 50%, and 75% volume replacement. The dry-hematology method, the Clauss method, the prothrombin time (PT)-derived method, determination of antigen levels, and thromboelastometric fibrin formation were compared in plasma or whole blood samples. The effect of heparin on each assay was examined (0 to 6 IU/mL). Comparisons of dry-hematology and other methods were also conducted using ex vivo samples obtained from cardiac surgical patients (n = 60).RESULTS: In plasma samples, there were no significant differences between dry-hematology and the Clauss method, while dry-hematology showed lower fibrinogen levels compared with PT-derived and antigen level methods. The dry-hematology method yielded acceptable concordance correlation coefficients (Pc) with the Clauss method, the PT-derived method, and fibrinogen antigen levels (Pc = 0.91-0.99). The type of diluents and heparin affected the results of the PT-derived method and thromboelastometric assay, but not the dry-hematology method. In cardiac surgical patients, the overall correlation in fibrinogen levels between dry-hematology and the other methods was comparable to the results from in vitro dilution experiments. The dry-hematology reported higher fibrinogen values in whole blood compared with those measured in plasma samples, but hematocrit adjustment decreased the bias between whole blood and plasma samples from 73 mg/dL (95% prediction interval: 40, 106) to -13 mg/dL (95% prediction interval: -35, 8.5).CONCLUSIONS: This study demonstrated that fibrinogen levels can be accurately assessed by the dry-hematology method in plasma and the results are not affected by heparin or colloids. For whole blood fibrinogen measurements by dry-hematology, hematocrit adjustment is necessary to compensate for dynamic changes in hematocrit in perioperative bleeding settings.