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.
Full Title of Study: “Establishment for Prediction Model of Intraoperative Blood Transfusion for Patients With Pelvic Fracture in China: A Multicenter Observational Study”
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: August 1, 2019
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.
2.3.2 Reasonably standardize the objective and subjective indicators of different units and different institutions.
2.4 Expected research results Intraoperative blood transfusion prediction model and window for patients with pelvic fractures.
2.5 Assessment indicators Published 1-2 papers. Create a visual applet and put it into trial.
Arms, Groups and Cohorts
- Pelvic fracture patients
- (1) 1<Age<80, and Chinese residents living in China more than 3 years; (2) Hemoglobin value less than 100g/L during hospitalization; Not suffered from pelvic fracture within 3 months; Not suffer from pathological fractures of the pelvis caused by malignant tumors; without chronic anemia and coagulopathy; accept blood transfusion
Clinical Trial Outcome Measures
- Matta Radiographic Scoring
- Time Frame: 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.
- Time Frame: 24 hours after the Patients’ Hospitalization
- Mortality during hospitalization
- Hb difference
- Time Frame: 24 hours after transfusion
- Hb difference before and after transfusion
- Pain assessed by the VAS
- Time Frame: 15 minutes, 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours postoperatively
- Change in the Pain Intensity Score (0-10 NRS)
- Postoperative Duration of Stay in Hospital of patients
- Time Frame: 52 Weeks
- The postoperative duration of stay in hospital of patients between the restrictive transfusion group and the liberal transfusion group are compared.
Participating in This Clinical Trial
- (1) 1<Age<80, and Chinese residents living in China more than 3 years;
- (2) Hemoglobin value less than 100g/L during hospitalization;
- (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
Gender Eligibility: All
Minimum Age: 1 Year
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- The Third Xiangya Hospital of Central South University
- Beijing Shijitan Hospital
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Rong Gui, Ph.D, 13975199279, email@example.com
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