NCT03855644

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

January 25, 2019

Last Update Submit

February 25, 2019

Conditions

Pelvic FractureTransfusion ReactionBlood Transfusion Complication

Keywords

Pelvic FracturePredictive ModelBlood TransfusionPerioperative period

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Hb difference

    24 hours 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

  • Postoperative Duration of Stay in Hospital of patients

    52 Weeks

Study Arms (1)

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

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Xiangya Hospital

Changsha, Hunan, 410013, China

RECRUITING

Related Publications (7)

  • 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.

    PMID: 19952241BACKGROUND

  • 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.

    PMID: 25086126BACKGROUND

  • 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.

    PMID: 21063578BACKGROUND

  • 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.

    PMID: 22168590BACKGROUND

  • 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.

    PMID: 16617259BACKGROUND

  • 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.

    PMID: 27865687BACKGROUND

  • 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.

    PMID: 16766790BACKGROUND

MeSH Terms

Conditions

Hip FracturesTransfusion Reaction

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesHematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Central Study Contacts

Rong Gui, Ph.D

CONTACT

13975199279aguirong@163.com

Huang Xueyuan, Mater degree

CONTACT

152731571842458481936@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 27, 2019

Study Start

April 5, 2019

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)