Condition Requiring Rapid Transfusion During Liver Transplantation SurgeryNCT01331889
Effect of Rapid Transfusion With Fluid Management System (FMS) on Plasma Potassium in Liver Transplantation Recipients
An observational study of Condition Requiring Rapid Transfusion During Liver Transplantation Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However, potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in the reservoir of rapid infusion system and its effect on the plasma potassium change during rapid transfusion are unknown. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Condition Requiring Rapid Transfusion During Liver Transplantation Surgery
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Apr 2016
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult liver transplantation recipients
Who may be able to join
- preoperative anemia (hemoglobin < 10 g/dl)
- preoperative coagulopathy
Who cannot join
- children under age 18
- low risk of intraoperative bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potassium Change in the Fluid Management System (FMS) Reservoir and Its Effect on the Plasma Potassium Concentration During Liver Transplantation Surgery
Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However, potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in the reservoir of rapid infusion system and its effect on the plasma potassium change during rapid transfusion are unknown. This study is designed to investigate these changes while massive transfusion is performed during liver transplantation surgery.
- Keywords
- transfusion, liver transplantation, potassium
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 |
|---|---|---|
| Potassium concentration | plasma potassium concentrations in the Fluid Management System (FMS) reservoir, arterial blood, and central venous blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
potassium concentration in the Fluid Management System (FMS) reservoir
During bolus transfusion (300ml) of blood mixture, blood sample is taken from the side port of infusion line of Fluid Management System (FMS) when 150 ml of blood mixture was transfused. Because the priming volume of the internal circuit is approximately 100 ml, blood sample that was taken after 150 ml transfusion represents the content in the reservoir.
Measured: after transfusion of 150 ml of blood mixture
Secondary outcomes (1)
plasma potassium of the patient
Just before transfusion starts, blood samples are taken from the central venous catheter and arterial line at the same time to measure baseline values. At the immediate end of transfusion, blood samples are taken again from the same sites to measure the resultant changes.
Measured: before and after transfuison of 300 ml of blood mixture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condition Requiring Rapid Transfusion During Liver Transplantation SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University
- Responsible party
- Principal investigator, Chul-Woo Jung, Seoul National University Hospital
- Investigators
- Chul-Woo Jung, MD. PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331889
- Sponsor's protocol ID
- FMS_potassium
- Status last verified
- Jul 2016
- First submitted
- 5 Apr 2011
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potassium Change in the Fluid Management System (FMS) Reservoir and Its Effect on the Plasma Potassium Concentration During Liver Transplantation Surgery
- ClinicalTrials.gov ID
- NCT01331889
- Acronym / sponsor ID
- FMS_potassium
- Keywords
- transfusion, liver transplantation, potassium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Apr 2011 (estimated)
- 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.
Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However, potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in the reservoir of rapid infusion system and its effect on the plasma potassium change during rapid transfusion are unknown. This study is designed to investigate these changes while massive transfusion is performed during liver transplantation surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potassium concentration | – | –plasma potassium concentrations in the Fluid Management System (FMS) reservoir, arterial blood, and central venous blood |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult liver transplantation recipients
Key inclusion criteria (2 listed)
- preoperative anemia (hemoglobin < 10 g/dl)
- preoperative coagulopathy
Key exclusion criteria (2 listed)
- children under age 18
- low risk of intraoperative bleeding
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
potassium concentration in the Fluid Management System (FMS) reservoir
Time frame: after transfusion of 150 ml of blood mixture
During bolus transfusion (300ml) of blood mixture, blood sample is taken from the side port of infusion line of Fluid Management System (FMS) when 150 ml of blood mixture was transfused. Because the priming volume of the internal circuit is approximately 100 ml, blood sample that was taken after 150 ml transfusion represents the content in the reservoir.
1 secondary outcome
plasma potassium of the patient
Time frame: before and after transfuison of 300 ml of blood mixture
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 11 Jul 2016.
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.
Chul-Woo Jung, MD. PhD principal investigator
Seoul National University 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 Condition Requiring Rapid Transfusion During Liver Transplantation Surgery, run by Seoul National University Hospital 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 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 11 Jul 2016. 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?
potassium concentration in the Fluid Management System (FMS) reservoir (time frame: after transfusion of 150 ml of blood mixture). 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 11 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.