Pelvic FracturePBMNCT03855644
Blood Transfusion Among Patients With Pelvic Fracture in China
An observational study of Pelvic Fracture and Transfusion Reaction, run by The Third Xiangya Hospital of Central South University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Pelvic Fracture, Transfusion Reaction, Blood Transfusion Complication
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2019to 1 Sep 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pelvic fractures who meet the standard in China, 1<Age<80.
Who may be able to join
- (1) 1<Age<80, and Chinese residents living in China more than 3 years;
- (2) Hemoglobin value less than 100g/L during hospitalization;
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Xiangya Hospital
Changsha, Hunan, 410013
Rong Gui, Ph.D, 13975199279, aguirong@163.com
Huang Xueyuan, Master Degree, 15273157184, 2458481936@qq.com
About this study
Official title: 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.
Read the 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.
- Keywords
- Pelvic Fracture, Predictive Model, Blood Transfusion, Perioperative period
- Medical subject headings
- Hip Fractures, Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months of postoperation
Mortality
Mortality during hospitalization
Measured: 24 hours after the Patients' Hospitalization
Secondary outcomes (3)
Hb difference
Hb difference before and after transfusion
Measured: 24 hours after transfusion
Pain assessed by the VAS
Change in the Pain Intensity Score (0-10 NRS)
Measured: 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
The postoperative duration of stay in hospital of patients between the restrictive transfusion group and the liberal transfusion group are compared.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start5 Apr 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, The Affiliated Hospital Of Southwest Medical University, Zhejiang Provincial People's Hospital, Central South University, Qilu Hospital of Shandong University, Beijing Aerospace General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855644
- Sponsor's protocol ID
- SXKThirdXiangyaHCSU
- Acronym
- PBM
- Status last verified
- Feb 2019
- First submitted
- 25 Jan 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19952241Perkins 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.
PubMed 25086126Santana-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.
PubMed 21063578Carson 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.
PubMed 22168590Nathens 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.
PubMed 16617259Ohmori 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.
PubMed 27865687Hardy 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.
PubMed 16766790
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment for Prediction Model of Intraoperative Blood Transfusion for Patients With Pelvic Fracture in China: A Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT03855644
- Acronym / sponsor ID
- PBM / SXKThirdXiangyaHCSU
- Keywords
- Pelvic Fracture, Predictive Model, Blood Transfusion, Perioperative period
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, The Affiliated Hospital Of Southwest Medical University, Zhejiang Provincial People's Hospital, Central South University, Qilu Hospital of Shandong University, Beijing Aerospace General Hospital
- Study start
- 5 Apr 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pelvic fractures who meet the standard in China, 1<Age<80.
Key inclusion criteria (2 listed)
- (1) 1<Age<80, and Chinese residents living in China more than 3 years;
- (2) Hemoglobin value less than 100g/L during hospitalization;
Key exclusion criteria (4 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Matta Radiographic Scoring
Time frame: 6 months of postoperation
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.
Mortality
Time frame: 24 hours after the Patients' Hospitalization
Mortality during hospitalization
3 secondary outcomes
Hb difference
Time frame: 24 hours after transfusion
Pain assessed by the VAS
Time frame: 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
Time frame: 52 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 19952241Sathy 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.
- Background: PubMed 25086126Perkins 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.
- Background: PubMed 21063578Santana-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.
- Background: PubMed 22168590Carson 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.
- Background: PubMed 16617259Nathens 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.
- Background: PubMed 27865687Ohmori 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.
- Background: PubMed 16766790Hardy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fracture and Transfusion Reaction, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Gui, Ph.D (13975199279, aguirong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matta Radiographic Scoring (time frame: 6 months of postoperation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03855644, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.