Blood Loss, PostoperativeNCT06189911
Perioperative Blood Transfusion in Open Liver Resection
An observational study of Blood Loss, Postoperative, run by Chiang Mai University.
Trial summary
This observational study is specifically designed to identify the pre-operative risk factors that significantly contribute to perioperative packed red cell transfusions in open liver resection procedures. The main question it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Postoperative
- What is being tested?
- Open liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,201 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 1 Jan 2023
- 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: All adult patients who underwent an elective open liver resection in our specialized hepato-biliary center from January 2006 through December 2017
Who may be able to join
- All genders age above 18 year old who underwent open liver resection from 2006-2017
- Elective open liver resection
Who cannot join
- Patients who death during the course of a surgical operation
About this study
Official title: The Risk Factors for Perioperative Blood Transfusion in Open Liver Resection, a Retrospective Cohort Study Development of a Transfusion Scoring System to Predict the Requirement for Perioperative Blood Transfusion in Open Liver Resection
This observational study is specifically designed to identify the pre-operative risk factors that significantly contribute to perioperative packed red cell transfusions in open liver resection procedures.
The main question it aims to answer are:
- What are the risk factors of peri-operative blood transfusion in open liver resection procedures
- What are the difference outcomes between patients who receive blood transfusion and the other group.
Researcher will compare perioperative factor and post operative outcomes between transfused and non-transfused group
Read the detailed description
After approval of the study protocol from the institutional review board of Chiangmai University (Approval number: ANE-2564-08020), we performed a retrospective review of all patients who underwent an elective open liver resection in our specialized hepato-biliary center from January 2006 through December 2017. This retrospective inquiry comprised 808 patients.
The data was systematically retrieved from electronic medical records. Baseline characteristics including age, gender, body mass index (BMI), co-morbidity, American Society of Anesthesiologists (ASA) classification, diagnosis, hepatitis profile, Child-Pugh classification, cirrhosis, the largest tumor size, previous liver resection, and pre-operative laboratory investigations were collected.
The following intra-operative data were collected: type of liver resection, hilar resection, vascular reconstruction, volume and type of fluid administration, estimated blood loss, packed red cell and blood product transfusion, and operation time. The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology
- Conditions
- Blood Loss, Postoperative
- Being tested
- Open liver resection
- Keywords
- liver resection, risk factors, blood transfusion, scoring system
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open liver resectionProcedure or surgery
The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology
| Study group | Role | What they receive |
|---|---|---|
| transfused | Group of patients who received perioperative blood transfusions which was defined as the transfusion of packed red cells during the operation and 48 hours after surgery. Receives: Procedure: Open liver resection | |
| non-transfused | Group of patients who did not received perioperative blood transfusions Receives: Procedure: Open liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pre-operative risk factors of perioperative packed red cell transfusions in open liver resection procedures.
Significant risk factors for perioperative blood transfusion were determined by factors with a p-value < 0.05 derived from the multivariable logistic regression analysis. This analysis facilitated adjustments for potential confounders to identify the independent risk factors associated with perioperative blood transfusion
Measured: the transfusion of packed red cells during the operation and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2006
- Primary completion31 Dec 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, PostoperativeStudies of the same condition, open and under way.
- 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
- 1,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warangkana Lapisatepun, Chiang Mai University
- Investigators
- Warangkana Lapisatepun, M.D., Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189911
- Sponsor's protocol ID
- ANE-2564-08020
- Status last verified
- Feb 2024
- First submitted
- 19 Dec 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Did not state about IPD sharing in the proposal which proposed to institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk Factors for Perioperative Blood Transfusion in Open Liver Resection, a Retrospective Cohort Study Development of a Transfusion Scoring System to Predict the Requirement for Perioperative Blood Transfusion in Open Liver Resection
- ClinicalTrials.gov ID
- NCT06189911
- Acronym / sponsor ID
- ANE-2564-08020
- Conditions
- Blood Loss, Postoperative
- Keywords
- liver resection, risk factors, blood transfusion, scoring system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,201 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 5 Jan 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 observational study is specifically designed to identify the pre-operative risk factors that significantly contribute to perioperative packed red cell transfusions in open liver resection procedures.
The main question it aims to answer are:
- What are the risk factors of peri-operative blood transfusion in open liver resection procedures
- What are the difference outcomes between patients who receive blood transfusion and the other group.
Researcher will compare perioperative factor and post operative outcomes between transfused and non-transfused group
Detailed description
After approval of the study protocol from the institutional review board of Chiangmai University (Approval number: ANE-2564-08020), we performed a retrospective review of all patients who underwent an elective open liver resection in our specialized hepato-biliary center from January 2006 through December 2017. This retrospective inquiry comprised 808 patients.
The data was systematically retrieved from electronic medical records. Baseline characteristics including age, gender, body mass index (BMI), co-morbidity, American Society of Anesthesiologists (ASA) classification, diagnosis, hepatitis profile, Child-Pugh classification, cirrhosis, the largest tumor size, previous liver resection, and pre-operative laboratory investigations were collected.
The following intra-operative data were collected: type of liver resection, hilar resection, vascular reconstruction, volume and type of fluid administration, estimated blood loss, packed red cell and blood product transfusion, and operation time. The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transfused | – | Procedure: Open liver resectionGroup of patients who received perioperative blood transfusions which was defined as the transfusion of packed red cells during the operation and 48 hours after surgery. |
| non-transfused | – | Procedure: Open liver resectionGroup of patients who did not received perioperative blood transfusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who underwent an elective open liver resection in our specialized hepato-biliary center from January 2006 through December 2017
Key inclusion criteria (2 listed)
- All genders age above 18 year old who underwent open liver resection from 2006-2017
- Elective open liver resection
Key exclusion criteria (1 listed)
- Patients who death during the course of a surgical operation
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 |
|---|---|---|
| Open liver resectionThe definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology | Procedure or surgery | non-transfused, transfused |
Primary outcome
the pre-operative risk factors of perioperative packed red cell transfusions in open liver resection procedures.
Time frame: the transfusion of packed red cells during the operation and 48 hours after surgery
Significant risk factors for perioperative blood transfusion were determined by factors with a p-value < 0.05 derived from the multivariable logistic regression analysis. This analysis facilitated adjustments for potential confounders to identify the independent risk factors associated with perioperative blood 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 1 Mar 2024.
- Individual participant dataSharing planned: No. Did not state about IPD sharing in the proposal which proposed to institutional review board.
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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.
Warangkana Lapisatepun, M.D. principal investigator
Chiang Mai University
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss, Postoperative, run by Chiang Mai University.
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 1 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
the pre-operative risk factors of perioperative packed red cell transfusions in open liver resection procedures. (time frame: the transfusion of packed red cells during the operation and 48 hours after surgery). 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 1 Mar 2024.