Orthopedic DisorderNCT01934907
Transfusion Reaction by Washed Red Blood Cell (RBC)
A study testing Washing of packed RBC by normal saline in people with Orthopedic Disorder, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Washing of packed RBC by normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Aug 2016
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total hip replacement arthroplasty
Who cannot join
- Patients who do not agree with this clinical study.
- Patients who have a history of transfusion for recent 1 month.
- Patients who have rare blood types.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 443-607
About this study
The hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion.
- Conditions
- Orthopedic Disorder
- Being tested
- Washing of packed RBC by normal saline
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Washing of packed RBC by normal salineOther
| Study group | Role | What they receive |
|---|---|---|
| washed RBC | Experimental | Packed RBCs are Washed and then, transfused. Receives: Other: Washing of packed RBC by normal saline |
| pack RBC | No intervention | Packed RBCs are transfused. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication by transfusion
Measured: Operation day and during postoperative 5 days
Secondary outcomes (2)
Total units of RBC transfused.
Measured: On the operation day and during the postoperative 5 days
Hemoglobin
Measured: 1 day before the operation day and postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934907
- Sponsor's protocol ID
- B-1307/212-009
- Status last verified
- Oct 2017
- First submitted
- 22 Aug 2013
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Reaction by Washed Red Blood Cell (RBC)
- ClinicalTrials.gov ID
- NCT01934907
- Acronym / sponsor ID
- B-1307/212-009
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Sep 2013 (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 hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| washed RBC | Experimental | Other: Washing of packed RBC by normal salinePacked RBCs are Washed and then, transfused. |
| pack RBC | No intervention | –Packed RBCs are transfused. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing total hip replacement arthroplasty
Key exclusion criteria (3 listed)
- Patients who do not agree with this clinical study.
- Patients who have a history of transfusion for recent 1 month.
- Patients who have rare blood types.
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 |
|---|---|---|
| Washing of packed RBC by normal saline | Other | washed RBC |
Primary outcome
Complication by transfusion
Time frame: Operation day and during postoperative 5 days
2 secondary outcomes
Total units of RBC transfused.
Time frame: On the operation day and during the postoperative 5 days
Hemoglobin
Time frame: 1 day before the operation day and postoperative 1 day
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 Oct 2017.
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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?
A study testing Washing of packed RBC by normal saline in people with Orthopedic Disorder, run by Seoul National University Bundang 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 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 11 Oct 2017. 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?
Complication by transfusion (time frame: Operation day and during postoperative 5 days). 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 Oct 2017.