Blood Transfusion Among Patients With Pelvic Fracture in China (PBM)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Huang Xueyuan, Mater degree; Phone Number: 15273157184; Email: 2458481936@qq.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Third Xiangya Hospital
      • Contact: Huang Xueyuan, Master Degree; Phone Number: 15273157184; Email: 2458481936@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with pelvic fractures who meet the standard in China, 1<Age<80.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Matta Radiographic Scoring	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.	6 months of postoperation
Mortality	Mortality during hospitalization	24 hours after the Patients' Hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Duration of Stay in Hospital of patients	The postoperative duration of stay in hospital of patients between the restrictive transfusion group and the liberal transfusion group are compared.	52 Weeks
Hb difference	Hb difference before and after transfusion	24 hours after transfusion
Pain assessed by the VAS	Change in the Pain Intensity Score (0-10 NRS)	15 minutes, 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours postoperatively

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Collaborators: Qilu Hospital of Shandong University; Beijing Shijitan Hospital, Capital Medical University; Central South University; Zhejiang Provincial People's Hospital; The Affiliated Hospital Of Southwest Medical University; Beijing Aerospace General Hospital

Publications and helpful links

General Publications

• Carson JL, Terrin ML, Noveck H, Sanders DW, Chaitman BR, Rhoads GG, Nemo G, Dragert K, Beaupre L, Hildebrand K, Macaulay W, Lewis C, Cook DR, Dobbin G, Zakriya KJ, Apple FS, Horney RA, Magaziner J; FOCUS Investigators. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.
• Sathy AK, Starr AJ, Smith WR, Elliott A, Agudelo J, Reinert CM, Minei JP. The effect of pelvic fracture on mortality after trauma: an analysis of 63,000 trauma patients. J Bone Joint Surg Am. 2009 Dec;91(12):2803-10. doi: 10.2106/JBJS.H.00598.
• Perkins ZB, Maytham GD, Koers L, Bates P, Brohi K, Tai NR. Impact on outcome of a targeted performance improvement programme in haemodynamically unstable patients with a pelvic fracture. Bone Joint J. 2014 Aug;96-B(8):1090-7. doi: 10.1302/0301-620X.96B8.33383.
• Santana-Cabrera L, Rodriguez Gonzalez F, Palacios MS. Delayed perforation of the sigmoid colon following a major pelvic fracture. J Emerg Trauma Shock. 2010 Oct;3(4):425-6. doi: 10.4103/0974-2700.70770. No abstract available.
• Nathens AB. Massive transfusion as a risk factor for acute lung injury: association or causation? Crit Care Med. 2006 May;34(5 Suppl):S144-50. doi: 10.1097/01.CCM.0000214309.95032.65.
• Ohmori T, Matsumoto T, Kitamura T, Tamura R, Tada K, Inoue T, Hayashi T, Numoto K, Tokioka T. Scoring system to predict hemorrhage in pelvic ring fracture. Orthop Traumatol Surg Res. 2016 Dec;102(8):1023-1028. doi: 10.1016/j.otsr.2016.09.007. Epub 2016 Nov 17.
• Hardy JF, de Moerloose P, Samama CM; Members of the Groupe d'Interet en Hemostase Perioperatoire. Massive transfusion and coagulopathy: pathophysiology and implications for clinical management. Can J Anaesth. 2006 Jun;53(6 Suppl):S40-58. doi: 10.1007/BF03022251.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 5, 2019
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (ACTUAL): February 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Blood Transfusion; Perioperative period; Pelvic Fracture; Predictive Model
• Additional Relevant MeSH Terms: Immune System Diseases; Wounds and Injuries; Leg Injuries; Hematologic Diseases; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Transfusion Reaction
• Other Study ID Numbers: SXKThirdXiangyaHCSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No