Blood Transfusion Among Patients With Pelvic Fracture in China

• Conditions: Pelvic Fracture; Transfusion Reaction; Blood Transfusion Complication

• Registration Number: NCT03855644
• Lead Sponsor: The Third Xiangya Hospital of Central South University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-01-25
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-25
• Last Update Submitted: 2019-02-25
• Study First Posted: 2019-02-27
• Last Update Posted: 2019-02-27
• Study Start: 2019-04-05
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

• (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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Matta Radiographic Scoring	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	24 hours after the Patients' Hospitalization	Mortality during hospitalization

Secondary Outcome Measures

Name	Time	Method
Hb difference	24 hours after transfusion	Hb difference before and 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	Change in the Pain Intensity Score (0-10 NRS)
Postoperative Duration of Stay in Hospital of patients	52 Weeks	The postoperative duration of stay in hospital of patients between the restrictive transfusion group and the liberal transfusion group are compared.

Trial Locations

Locations (1)

Third Xiangya Hospital; 🇨🇳 Changsha, Hunan, China