OrthopedicsNCT02575820
Old Blood and Postoperative Complications
An observational study of Orthopedics and Postoperative Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators sought to examine the effects of 'old' red blood cells on mortality and morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators hypothesis is that patients have an increased risk of mortality and infection after 'old' red blood cells transfusions compared with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedics, Postoperative Complications, Red Blood Cells
- What is being tested?
- Old red blood cells transfusion and New red blood cells transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent revision total hip replacement
Who may be able to join
- Patients who underwent revision total hip replacement
Who cannot join
- Patients who were not given red blood cells
- Patients who were given two units of which one unit was old and one was new
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, 13620
About this study
Official title: The Effects of Old Red Blood Cell Transfusion on Morbidity in Patients Undergoing Revision Total Hip Arthroplasty: Retrospective Study
The investigators sought to examine the effects of 'old' red blood cells on mortality and morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators hypothesis is that patients have an increased risk of mortality and infection after 'old' red blood cells transfusions compared with those who received 'new' transfusions.
- Conditions
- Orthopedics, Postoperative Complications, Red Blood Cells
- Being tested
- Old red blood cells transfusion, New red blood cells transfusion
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Old red blood cells transfusionProcedure or surgery
Red blood cells (shelf life > 14 days) transfusion during the operation (total hip replacement arthroplasty)
New red blood cells transfusionProcedure or surgery
Red blood cells (shelf life =< 14 days) transfusion during the operation (total hip replacement arthroplasty)
| Study group | Role | What they receive |
|---|---|---|
| RBC_old | shelf life of red blood cells of 15 or higher days Receives: Procedure: Old red blood cells transfusion | |
| RBC_new | shelf life of red blood cells 14 or lower days Receives: Procedure: New red blood cells transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: postoperative 7 days
Sepsis
Measured: postoperative 7 days
Wound infection
Measured: postoperative 7 days
Postoperative delirium
Measured: postoperative 7 days
Postoperative bleeding
Measured: postoperative 7 days
Secondary outcomes (7)
Transfusion related lung injury
Measured: postoperative 7 days
Pulmonary edema
Measured: postoperative 7 days
Pulmonary effusion
Measured: postoperative 7 days
Myocardial ischemia
Measured: postoperative 7 days
Pulmonary thromboembolism
Measured: postoperative 7 days
Renal failure
Measured: postoperative 7 days
Hepatic failure
Measured: postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Sample size was too small to evaluate the clinical implications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthopedicsStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Jung Shin, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575820
- Sponsor's protocol ID
- B-1510/318-112
- Status last verified
- May 2016
- First submitted
- 11 Oct 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Old Red Blood Cell Transfusion on Morbidity in Patients Undergoing Revision Total Hip Arthroplasty: Retrospective Study
- ClinicalTrials.gov ID
- NCT02575820
- Acronym / sponsor ID
- B-1510/318-112
- Conditions
- Orthopedics, Postoperative Complications, Red Blood Cells
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sample size was too small to evaluate the clinical implications.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Oct 2015 (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.
The investigators sought to examine the effects of 'old' red blood cells on mortality and morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators hypothesis is that patients have an increased risk of mortality and infection after 'old' red blood cells transfusions compared with those who received 'new' transfusions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBC_old | – | Procedure: Old red blood cells transfusionshelf life of red blood cells of 15 or higher days |
| RBC_new | – | Procedure: New red blood cells transfusionshelf life of red blood cells 14 or lower days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent revision total hip replacement
Key inclusion criteria (1 listed)
- Patients who underwent revision total hip replacement
Key exclusion criteria (2 listed)
- Patients who were not given red blood cells
- Patients who were given two units of which one unit was old and one was new
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 |
|---|---|---|
| Old red blood cells transfusionRed blood cells (shelf life > 14 days) transfusion during the operation (total hip replacement arthroplasty) | Procedure or surgery | RBC_old |
| New red blood cells transfusionRed blood cells (shelf life =< 14 days) transfusion during the operation (total hip replacement arthroplasty) | Procedure or surgery | RBC_new |
Primary outcome
Mortality
Time frame: postoperative 7 days
Sepsis
Time frame: postoperative 7 days
Wound infection
Time frame: postoperative 7 days
Postoperative delirium
Time frame: postoperative 7 days
Postoperative bleeding
Time frame: postoperative 7 days
7 secondary outcomes
Transfusion related lung injury
Time frame: postoperative 7 days
Pulmonary edema
Time frame: postoperative 7 days
Pulmonary effusion
Time frame: postoperative 7 days
Myocardial ischemia
Time frame: postoperative 7 days
Pulmonary thromboembolism
Time frame: postoperative 7 days
Renal failure
Time frame: postoperative 7 days
Hepatic failure
Time frame: postoperative 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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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 Orthopedics and Postoperative Complications, 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 1 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: withdrawn, as of the sponsor's last update on 13 May 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 was withdrawn before enrolling participants, so there are no results.
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?
Mortality (time frame: postoperative 7 days). The study lists 5 primary outcomes in all. 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 13 May 2016.