Clinical trial NCT03855644: Blood Transfusion Among Patients With Pelvic Fracture in China
Official title: Establishment for Prediction Model of Intraoperative Blood Transfusion for Patients With Pelvic Fracture in China: A Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Fracture
Transfusion Reaction
Blood Transfusion Complication
Keywords: Pelvic Fracture
Predictive Model
Blood Transfusion
Perioperative period
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Beijing Shijitan Hospital, Capital Medical University
name: The Affiliated Hospital Of Southwest Medical University
name: Zhejiang Provincial People's Hospital
name: Central South University
name: Qilu Hospital of Shandong University
name: Beijing Aerospace General Hospital
First posted: 2019-02-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pelvic fractures who meet the standard in China, 1\<Age\<80.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Matta Radiographic Scoring
timeFrame: 6 months of postoperation
measure: Mortality
timeFrame: 24 hours after the Patients' Hospitalization
Secondary outcomes:
measure: Hb difference
timeFrame: 24 hours after transfusion
measure: Pain assessed by the VAS
timeFrame: 15 minutes, 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours postoperatively
measure: Postoperative Duration of Stay in Hospital of patients
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: Third Xiangya Hospital
state: Hunan
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.