Massive TransfusionNCT06701747
A Nomogram Predicting the Risk of High-dose Transfusion in Non-cardiac Surgery
An observational study of Massive Transfusion and Nomogram Model, run by West China Hospital at 1 site in China.
Trial summary
This retrospective study was designed to develop a preoperative nomogram, validated both internally and externally, to supply an individual and precise tool for predicting the probability that patients will require perioperative transfusion therapy. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Massive Transfusion, Nomogram Model
- How many people
- 11,197 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Jul 2024
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective study included 【】patients who received RBCs transfusion during non-cardiac surgery at West China Hospital between January 2018 and June 2024.
Who may be able to join
- Patients undergoing non-cardiac surgery during hospitalization.
- Patients receiving allogeneic RBCs transfusion within 24 hours during and after surgery.
Who cannot join
- Age under 15 years.
- Patients with incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Nomogram Predicting the Risk of Perioperative High-dose Transfusion in Non-cardiac Surgery
This retrospective study was designed to develop a preoperative nomogram, validated both internally and externally, to supply an individual and precise tool for predicting the probability that patients will require perioperative transfusion therapy.
Read the detailed description
Perioperative red blood cells (RBCs) transfusion is a necessary guarantee for surgical surgery and one of the indispensable means in modern medical treatment. In recent years, with the continuous improvement of medical standards, various major and complex surgeries have been carried out. The total number of patients receiving surgical treatment increased year by year, and the demand for surgical blood has also increased rapidly. Although unpaid blood donation has been vigorously advocated in recent years, the supply of blood products are still difficult to meet the growing demand for clinical blood. RBCs transfusion is often associated with unavoidable complications such as anaphylaxis and transfusion-related acute lung injury, which may lead to delayed recovery, increased hospital stay and medical costs, and result in serious adverse effects and even death.
Hemorrhage is a common complication of surgery. The effect of blood transfusion treatment and the patient's recovery process will be affected by the amount of blood transfused during the perioperative period. Similarly, blood products that are prepared in advance for surgery often remains unused perioperatively, leading to the waste of valuable blood resources and an increase in hospital expenses. Hemorrhage is one of the leading causes of death in various clinical situations, such as severe trauma, heart surgery, and traffic accidents.Timely and effective high-dose transfusion is directly related to life and death. However, high-dose transfusion may also lead to dilution coagulopathy, increased risk of bleeding, and imbalance in the internal environment.
In brief, there is an urgent requirement for a systematic, evidence-driven tool to comprehensively weigh the risks and benefits of high-dose RBCs transfusion in clinical practice.
- Conditions
- Massive Transfusion, Nomogram Model
- Keywords
- Massive transfusion, Red blood cells, Nomogram, Non-cardiac surgery, Patient blood management
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 |
|---|---|---|
| High-dose group | Receive RBCs transfusion over 1600mL | |
| No-high-dose group | Receive RBCs transfusion under 1600mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBCs transfusion volume
The total volume of RBCs transfused within 24 from the start of transfusion.
Measured: Up to 24 hours after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive TransfusionStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,197 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701747
- Sponsor's protocol ID
- WCH20231634
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Nomogram Predicting the Risk of Perioperative High-dose Transfusion in Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT06701747
- Acronym / sponsor ID
- WCH20231634
- Conditions
- Massive Transfusion, Nomogram Model
- Keywords
- Massive transfusion, Red blood cells, Nomogram, Non-cardiac surgery, Patient blood management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,197 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 22 Nov 2024 (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.
This retrospective study was designed to develop a preoperative nomogram, validated both internally and externally, to supply an individual and precise tool for predicting the probability that patients will require perioperative transfusion therapy.
Detailed description
Perioperative red blood cells (RBCs) transfusion is a necessary guarantee for surgical surgery and one of the indispensable means in modern medical treatment. In recent years, with the continuous improvement of medical standards, various major and complex surgeries have been carried out. The total number of patients receiving surgical treatment increased year by year, and the demand for surgical blood has also increased rapidly. Although unpaid blood donation has been vigorously advocated in recent years, the supply of blood products are still difficult to meet the growing demand for clinical blood. RBCs transfusion is often associated with unavoidable complications such as anaphylaxis and transfusion-related acute lung injury, which may lead to delayed recovery, increased hospital stay and medical costs, and result in serious adverse effects and even death.
Hemorrhage is a common complication of surgery. The effect of blood transfusion treatment and the patient's recovery process will be affected by the amount of blood transfused during the perioperative period. Similarly, blood products that are prepared in advance for surgery often remains unused perioperatively, leading to the waste of valuable blood resources and an increase in hospital expenses. Hemorrhage is one of the leading causes of death in various clinical situations, such as severe trauma, heart surgery, and traffic accidents.Timely and effective high-dose transfusion is directly related to life and death. However, high-dose transfusion may also lead to dilution coagulopathy, increased risk of bleeding, and imbalance in the internal environment.
In brief, there is an urgent requirement for a systematic, evidence-driven tool to comprehensively weigh the risks and benefits of high-dose RBCs transfusion in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose group | – | –Receive RBCs transfusion over 1600mL |
| No-high-dose group | – | –Receive RBCs transfusion under 1600mL |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective study included 【】patients who received RBCs transfusion during non-cardiac surgery at West China Hospital between January 2018 and June 2024.
Key inclusion criteria (2 listed)
- Patients undergoing non-cardiac surgery during hospitalization.
- Patients receiving allogeneic RBCs transfusion within 24 hours during and after surgery.
Key exclusion criteria (2 listed)
- Age under 15 years.
- Patients with incomplete clinical data.
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
RBCs transfusion volume
Time frame: Up to 24 hours after transfusion
The total volume of RBCs transfused within 24 from the start of transfusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Massive Transfusion
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Predictors of In-Hospital Mortality in Severe Abdominal Trauma
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Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
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TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss
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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.
Ren Liao, M.D. principal investigator
West China Hospital
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 Massive Transfusion and Nomogram Model, run by West China Hospital 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 2 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: finished, as of the sponsor's last update on 22 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBCs transfusion volume (time frame: Up to 24 hours after transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024.