TransfusionsNCT06847490
Transfusion Prediction in Major Abdominal Surgery
An observational study of Transfusions, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The transfusion nomogram, integrating preoperative variables, may effectively predict intraoperative transfusion in major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfusions
- How many people
- 128,749 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jun 2024to 2 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adult patients (≥18 years old) who underwent major abdominal surgery at a tertiary medical center. The study population consists of patients with available preoperative clinical and laboratory data, allowing for the development of a predictive model for intraoperative blood transfusion. Patients with known hematologic disorders, coagulopathy, or prior transfusion before surgery are excluded to minimize confounding factors.
Who may be able to join
- Patients aged 18 years and older who underwent major abdominal surgery
Who cannot join
- Patients with known hematologic disease or coagulopathy
- Patients who received a blood transfusion before surgery
- Patients with incomplete data or missing laboratory values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Predictive Model for Transfusion in Major Abdominal Surgery
The transfusion nomogram, integrating preoperative variables, may effectively predict intraoperative transfusion in major abdominal surgery.
- Conditions
- Transfusions
- Being tested
- No intervention (observational study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This is an observational study aimed at developing and validating a predictive model for perioperative blood transfusion. The study utilizes retrospective clinical data from surgical patients to identify key risk factors associated with transfusion requirements. No experimental intervention will be applied to participants, as the study solely focuses on data analysis and model development.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative transfusion
The primary outcome measure is the occurrence of intraoperative blood transfusion. This includes any administration of red blood cells, plasma, or platelets during the surgical procedure. The study aims to predict transfusion requirements based on preoperative clinical factors.
Measured: From surgical incision to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start30 Jun 2024
- Primary completion20 Dec 2024
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TransfusionsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 128,749 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hoon Sim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847490
- Sponsor's protocol ID
- AMC (2024-1087)
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sim JH, Oh AR, Kim S, Park YS, Ha S, Kim JU. Development and validation of a predictive model for transfusion in major abdominal surgery: a multicentre retrospective study. Br J Anaesth. 2025 Sep;135(3):623-631. doi: 10.1016/j.bja.2025.05.048. Epub 2025 Jul 18.
PubMed 40681389
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Predictive Model for Transfusion in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06847490
- Acronym / sponsor ID
- AMC (2024-1087)
- Conditions
- Transfusions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128,749 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 26 Feb 2025 (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.
The transfusion nomogram, integrating preoperative variables, may effectively predict intraoperative transfusion in major abdominal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adult patients (≥18 years old) who underwent major abdominal surgery at a tertiary medical center. The study population consists of patients with available preoperative clinical and laboratory data, allowing for the development of a predictive model for intraoperative blood transfusion. Patients with known hematologic disorders, coagulopathy, or prior transfusion before surgery are excluded to minimize confounding factors.
Key inclusion criteria (1 listed)
- Patients aged 18 years and older who underwent major abdominal surgery
Key exclusion criteria (3 listed)
- Patients with known hematologic disease or coagulopathy
- Patients who received a blood transfusion before surgery
- Patients with incomplete data or missing laboratory values
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)This is an observational study aimed at developing and validating a predictive model for perioperative blood transfusion. The study utilizes retrospective clinical data from surgical patients to identify key risk factors associated with transfusion requirements. No experimental intervention will be applied to participants, as the study solely focuses on data analysis and model development. | Other | – |
Primary outcome
Intraoperative transfusion
Time frame: From surgical incision to the end of surgery
The primary outcome measure is the occurrence of intraoperative blood transfusion. This includes any administration of red blood cells, plasma, or platelets during the surgical procedure. The study aims to predict transfusion requirements based on preoperative clinical factors.
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 26 Feb 2025.
- Derived from this study: PubMed 40681389Sim JH, Oh AR, Kim S, Park YS, Ha S, Kim JU. Development and validation of a predictive model for transfusion in major abdominal surgery: a multicentre retrospective study. Br J Anaesth. 2025 Sep;135(3):623-631. doi: 10.1016/j.bja.2025.05.048. Epub 2025 Jul 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transfusions, run by Asan Medical Center at 1 site in South Korea.
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 1 inclusion and 3 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 26 Feb 2025. 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 South Korea. 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?
Intraoperative transfusion (time frame: From surgical incision to the end of surgery). 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 NCT06847490, which also lists 1 linked publication.
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 26 Feb 2025.