Monitoring of brain oxygen saturation (INVOS) in a protocol to direct blood transfusions during cardiac surgery: a prospective randomized clinical trial.
Monitoring of brain oxygen saturation (INVOS) in a protocol to direct blood transfusions during cardiac surgery: a prospective randomized clinical trial.
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DOI：
10.1186/1749-8090-8-145
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发表时间：
2013-06-07
影响因子：
1.6
通讯作者：
Karanikolas M
中科院分区：
文献类型：
--
作者：
Vretzakis G;Georgopoulou S;Stamoulis K;Tassoudis V;Mikroulis D;Giannoukas A;Tsilimingas N;Karanikolas M
输血在心脏手术中很常见，但与发病率和长期死亡率增加有关。减少心脏手术期间血液制品使用的努力包括限制液体以尽量减少血液稀释，以及指导输血决策的方案。 INVOS 是一种监测脑组织氧饱和度的方法，可用于指导输血决策。然而，INVOS（脑组织氧饱和度）作为心脏手术期间指导输血算法的一部分的作用尚未得到评估。本研究旨在调查 INVOS 作为心脏手术期间输血方案一部分的价值。对 150 名（每组 75 名）择期心脏手术患者进行的前瞻性、随机、盲法临床试验。该研究得到了机构伦理委员会的批准，所有患者都签署了书面知情同意书。数据最初是根据“治疗意向”进行分析，但随后也“按照方案”进行分析。当严格遵循方案时（“按照方案分析”），与对照组相比，接受 INVOS 监测的患者接受输血的患者数量显着减少（INVOS 组 70 名患者中的 46 名患者与对照组 67 名患者中的 55 名患者相比，p = 0.029）。同样，接受 INVOS 监测的患者在术中接受的红细胞输注单位显着减少（0.20±±0.50 vs. 0.52±±0.88，p=±0.008），住院期间整体红细胞输注量显着减少（1.31±±1.20 vs. 1.82±±1.46， p = 0.024）。当对所有患者（包括违反方案的患者）的数据进行分析（“意向治疗分析”）时，观察到的 INVOS 组输血量仍然显着减少（INVOS 组 75 名输血患者中的 51 名与对照组 75 名输血患者中的 63 名，p = 0.021），但每名患者的输血总数在各组之间没有显着差异（1.55 ± 1.97 vs 1.55 ± 1.97）。 1.84 ± 1.41，p = 0.288）。我们的数据表明，INVOS 可能是一个有用的工具，作为指导心脏手术中输血决策的算法的一部分。需要来自严格、精心设计的研究的额外数据来进一步评估 INVOS 在指导心脏手术输血中的作用，并规避本研究的局限性。 ClinicalTrials.gov：NCT00879463
Blood transfusions are common in cardiac surgery, but have been associated with increased morbidity and long-term mortality. Efforts to reduce blood product use during cardiac surgery include fluid restriction to minimize hemodilution, and protocols to guide transfusion decisions. INVOS is a modality that monitors brain tissue oxygen saturation, and could be useful in guiding decisions to transfuse. However, the role of INVOS (brain tissue oxygen saturation) as part of an algorithm to direct blood transfusions during cardiac surgery has not been evaluated. This study was conducted to investigate the value of INVOS as part of a protocol for blood transfusions during cardiac surgery. Prospective, randomized, blinded clinical trial, on 150 (75 per group) elective cardiac surgery patients. The study was approved by the Institution Ethics committee and all patients gave written informed consent. Data were initially analyzed based on “intention to treat”, but subsequently were also analyzed “per protocol”. When protocol was strictly followed (“per protocol analysis”), compared to the control group, significantly fewer patients monitored with INVOS received any blood transfusions (46 of 70 patients in INVOS group vs. 55 of 67 patients in the control group, p = 0.029). Similarly, patients monitored with INVOS received significantly fewer units of red blood cell transfusions intraoperatively (0.20 ± 0.50 vs. 0.52 ± 0.88, p = 0.008) and overall during hospital stay (1.31 ± 1.20 vs. 1.82 ± 1.46, p = 0.024). When data from all patients (including patient with protocol violation) were analyzed together (“intention to treat analysis”), the observed reduction of blood transfusions in the INVOS group was still significant (51 of 75 patients transfused in the INVOS group vs. 63 of 75 patients transfused in the control group, p = 0.021), but the overall number of units transfused per patient did not differ significantly between the groups (1.55 ± 1.97 vs. 1.84 ± 1.41, p = 0.288). Our data suggest that INVOS could be a useful tool as part of an algorithm to guide decisions for blood transfusion in cardiac surgery. Additional data from rigorous, well designed studies are needed to further evaluate the role of INVOS in guiding blood transfusions in cardiac surgery, and circumvent the limitations of this study. ClinicalTrials.gov: NCT00879463
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影响因子：
120.7
作者：
Hajjar, Ludhmila A.;Vincent, Jean-Louis;Auler, Jose O. C., Jr.
通讯作者：
Auler, Jose O. C., Jr.
DOI：
10.1016/j.injury.2011.04.015
发表时间：
2011-11-01
影响因子：
2.5
作者：
Papadopoulos, Georgios;Karanikolas, Menelaos;Berris, Alexandros
通讯作者：
Berris, Alexandros
影响因子：
2.9
作者：
Bracey, AW;Radovancevic, R;Cooley, DA
通讯作者：
Cooley, DA
影响因子：
2.9
作者：
Karkouti, K;Cohen, MM;Sher, GD
通讯作者：
Sher, GD
影响因子：
0.6
作者：
Vretzakis, George;Kleitsaki, Athina;Karanikolas, Menelaos
通讯作者：
Karanikolas, Menelaos