Blood Transfusion Among Patients With Pelvic Fracture in China

Pelvic Fracture Clinical Trial

— PBM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855644
• Other study ID #: SXKThirdXiangyaHCSU
• Status: Recruiting
• Start date: April 5, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: February 2019
• Source: The Third Xiangya Hospital of Central South University
• Contact: Rong Gui, Ph.D
• Phone: 13975199279
• Email: aguirong[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Transfusion Complication
• Fractures, Bone
• Hip Fractures
• Pelvic Fracture
• Transfusion Reaction

Locations

Country	Name	City	State
China	Third Xiangya Hospital	Changsha	Hunan

Sponsors (7)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University	Beijing Aerospace General Hospital, Beijing Shijitan Hospital, Central South University, Qilu Hospital of Shandong University, The Affiliated Hospital Of Southwest Medical University, Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

Hardy JF, de Moerloose P, Samama CM; Members of the Groupe d'Intérêt en Hémostase Périopératoire. Massive transfusion and coagulopathy: pathophysiology and implications for clinical management. Can J Anaesth. 2006 Jun;53(6 Suppl):S40-58. — View 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. Review. — View 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. — View 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. — View Citation

Santana-Cabrera L, Rodríguez González 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mortality	Mortality during hospitalization	24 hours after the Patients' Hospitalization
Secondary	Hb difference	Hb difference before and after transfusion	24 hours after transfusion
Secondary	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
Secondary	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