跳至主要内容
临床试验/NCT04058665
NCT04058665已完成不适用

Hemostatic Agent Use and Intraoperative Blood Loss in Lumbar Spine Surgery

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Total blood loss

研究概览

简要总结

Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. In particular the investigators are interested in determining whether FloSeal® contributes towards increased control over perioperative bleeding compared to other hemostatic agents for potential inclusion in a future bundled approach.

详细描述

Blood loss is a major concern in spine surgery. Within lumbar fusion surgery, one study estimated an average blood loss of 800 mL (range 100-3,100 mL) for non-instrumented fusion and 1,517 mL (range 360-7,000 mL) for instrumented fusions. Blood transfusions are required in an estimated 8% to 36% of patients undergoing spine surgery.Transfusion promotes tissue perfusion and oxygen delivery during extensive surgeries, yet carries with it rare but significant risks. These include acute lung injury, febrile reactions, allergic episodes, infection, and impaired immune response. Given these potential risks, strategies to minimize extensive blood loss and resultant transfusion are warranted.

Previously described approaches in the literature that can minimize blood loss during spine surgery include: hypotensive anesthesia, hemostatic agents (e.g. FloSeal®), antifibrinolytic medications, advanced bipolar cautery (e.g. Aquamantys®), autologous blood salvage (e.g. Cell Saver®), perioperative and intraoperative temperature, operative time, nutritional state, coagulopathy, restrictive transfusion triggers, and rotational thromboelastometry (ROTEM).

Researchers in several medical fields have attempted to delineate comprehensive anemia prevention strategies described as "blood-saving bundles". A bundle encapsulates multiple evidence-based interventions that result in improved patient outcomes-here with a focus on reduced blood loss-when combined versus when each intervention is used in isolation. Care bundles applied to intensive care unit treatment and pneumonia, sepsis, and acute kidney injury care have demonstrated improved clinical outcomes. However, no bundled protocol currently exists that aim to decrease blood loss and transfusion incidence during spine surgery. Moreover, no data exist that identify whether use of FloSeal® over other hemostatic agents as part of a bundled protocol results in decreased blood loss and transfusion rates, improved surgical outcomes, and improved cost effectiveness.

Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. In particular the investigators are interested in determining whether FloSeal® contributes towards increased control over perioperative bleeding compared to other hemostatic agents for potential inclusion in a future bundled approach.

This retrospective multivariate analysis will identify potential factors associated with increased blood loss and transfusion incidence. The investigators anticipate using these findings to develop a future bundled protocol for implementation in all patients undergoing spine surgery at Johns Hopkins Hospital after approval by the Institutional Review Board. Such a bundled protocol has the potential to improve surgical outcomes and decrease institutional costs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • Undergoing lumbar spine surgery
  • Surgery performed between July 1, 2016 and November 30, 2018
  • Surgery performed at the Johns Hopkins East Baltimore Campus
  • Available data on hemostatic agents used

排除标准

  • Age under 18
  • Surgery at location other than lumbar spine
  • Surgical details unavailable
  • Data unavailable for specified endpoints, including:
  • Hemostatic agent use
  • Blood loss
  • Operative time

结局指标

主要结局

Total blood loss

时间窗: 1 week

Cubic centimeters (cm\^3) of blood loss throughout the operation.

次要结局

  • Number of postoperative infections(Up to 3 months)
  • Length of hospital stay(Up to 1 month)
  • Transfusion cost(Up to 1 year)
  • Discharge disposition after surgery(Up to 1 month)
  • Overall cost of care during time in hospital(Up to 1 year)
  • Number of transfusion complications(Up to 1 month)
  • Operating room cost(Up to 1 year)
  • Number of medical complications(Up to 1 month)
  • Total length of hospital stay cost(Up to 1 year)
  • Hospital disposition after surgery(Up to 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Hemostatic Agent Use and Intraoperative Blood Loss... | 临床试验