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临床试验/NCT03855644
NCT03855644Unknown不适用

Establishment for Prediction Model of Intraoperative Blood Transfusion for Patients With Pelvic Fracture in China: A Multicenter Observational Study

The Third Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2019年4月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
Matta Radiographic Scoring

研究概览

简要总结

According to the patient's blood management concept, this study intends to collect basic information, surgical data, blood transfusion related data and patient prognosis data of patients with pelvic fractures, and to construct a predictive model of intraoperative blood transfusion in patients with pelvic fractures by multiple linear regression analysis. To guide physicians use blood accurately during surgery. Prompt doctors to reduce blood transfusion dose and improve patient prognosis by stopping bleeding and blood recovery before surgery.

详细描述

2.1 Research Objectives: This study aims to construct a blood transfusion model for pelvic fractures, to guide the rational use of blood during surgery, and to improve the prognosis of patients.

2.2 Research content: 2.2.1 Collect basic data, surgical data, blood transfusion related data and patient prognosis related data of patients with pelvic fractures.

2.2.2 Gradually incorporate and exclude data from multiple linear regression models.

2.2.3 Verify the specificity and sensitivity of the intraoperative blood transfusion prediction model.

2.2.4 Create a visualization window to guide clinical blood. 2.2.5 Put into clinical trial and feedback, and continue to verify 2.3 Key issues to be resolved 2.3.1 The factors related to intraoperative blood transfusion in patients with pelvic fractures (such as blood oxygenation, blood loss, HB value, intraoperative autologous blood recovery, blood pressure, heart rate, etc.) were initially screened by univariate analysis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Year 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) 1<Age<80, and Chinese residents living in China more than 3 years;
  • (2) Hemoglobin value less than 100g/L during hospitalization;

排除标准

  • (1) Participants who suffered from pelvic fracture within 3 months
  • (2) Participants who suffer from pathological fractures of the pelvis caused by malignant tumors
  • (3) Participants with chronic anemia and coagulopathy
  • (4) Participants who rufuse blood transfusion

结局指标

主要结局

Matta Radiographic Scoring

时间窗: 6 months of postoperation

Reductions were graded by the maximal displacement measured on the 3 standard views of the pelvis. Criteria were: excellent 4 mm or less, good 5 to 10 mm, fair 10 to 20 mm, and poor more than 20 mm.

Mortality

时间窗: 24 hours after the Patients' Hospitalization

Mortality during hospitalization

次要结局

  • Hb difference(24 hours after transfusion)
  • Pain assessed by the VAS(15 minutes, 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours postoperatively)
  • Postoperative Duration of Stay in Hospital of patients(52 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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