Blood Transfusion Among Patients With Pelvic Fracture in China

NCT ID: NCT03855644

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-05

Study Completion Date

2019-09-01

Brief Summary

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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

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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.

Conditions

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Pelvic Fracture Transfusion Reaction Blood Transfusion Complication

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Beijing Aerospace General Hospital

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Third Xiangya Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rong Gui, Ph.D

Role: CONTACT

13975199279

Huang Xueyuan, Mater degree

Role: CONTACT

15273157184

Facility Contacts

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Rong Gui, Ph.D

Role: primary

13975199279

Huang Xueyuan, Master Degree

Role: backup

15273157184

References

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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.

Reference Type BACKGROUND
PMID: 19952241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25086126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21063578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22168590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16617259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27865687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16766790 (View on PubMed)

Other Identifiers

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SXKThirdXiangyaHCSU

Identifier Type: -

Identifier Source: org_study_id

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