Avascular Necrosis of HipNCT01521858
THRA_hematologic Variables
An observational study of Avascular Necrosis of Hip, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Avascular Necrosis of Hip
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Feb 2013
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagosed with avascular necrosis of hip and undergoing total hip replacement arthroplasty
Who may be able to join
- avascular necrosis of hip
- total hip replacement arthroplasty
Who cannot join
- revision operation
- hematologic disease
- anticoagulant medication
- preoperative hemoglobin < 10 g/dl
- preoperative transfusion of red blood cells
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Gyounggi, 463-707
About this study
Official title: Relations Between Hematologic Variables and Postoperative Bleeding in Total Hip Replacement Arthroplasty
Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.
- Conditions
- Avascular Necrosis of Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative bleeding volume
Measured: at first postoperative day
Hemoglobin
Measured: preoperative 1 day and postoperative 1 day
hematocrit
Measured: preoperative 1 day and postoperative 1 day
platelet
Measured: preoperative 1 day and postoperative 1 day
prothrombin time_international normalized ratio
Measured: preoperative 1 day and postoperative 1 day
activated partial prothrombin time
Measured: preoperative 1 day and postoperative 1 day
fibrinogen concentration
Measured: preoperative 1 day and postoperative 1 day
Rotational thromboelastometry
Measured: preoperative 1 day and postoperative 1 day
Secondary outcomes (3)
volume of infused fluid during operation
Infused total crystalloid and colloid volume during the operation will be recorded.
Measured: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)
intraoperative urine output
Measured: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)
transfusion units
Red blood cell
Measured: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular Necrosis of HipStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 73 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
- NCT01521858
- Sponsor's protocol ID
- B_1111_140_103
- Status last verified
- Aug 2013
- First submitted
- 9 Jan 2012
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relations Between Hematologic Variables and Postoperative Bleeding in Total Hip Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT01521858
- Acronym / sponsor ID
- B_1111_140_103
- Conditions
- Avascular Necrosis of Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 31 Jan 2012 (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.
Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagosed with avascular necrosis of hip and undergoing total hip replacement arthroplasty
Key inclusion criteria (2 listed)
- avascular necrosis of hip
- total hip replacement arthroplasty
Key exclusion criteria (5 listed)
- revision operation
- hematologic disease
- anticoagulant medication
- preoperative hemoglobin < 10 g/dl
- preoperative transfusion of red blood cells
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
postoperative bleeding volume
Time frame: at first postoperative day
Hemoglobin
Time frame: preoperative 1 day and postoperative 1 day
hematocrit
Time frame: preoperative 1 day and postoperative 1 day
platelet
Time frame: preoperative 1 day and postoperative 1 day
prothrombin time_international normalized ratio
Time frame: preoperative 1 day and postoperative 1 day
activated partial prothrombin time
Time frame: preoperative 1 day and postoperative 1 day
fibrinogen concentration
Time frame: preoperative 1 day and postoperative 1 day
Rotational thromboelastometry
Time frame: preoperative 1 day and postoperative 1 day
3 secondary outcomes
volume of infused fluid during operation
Time frame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)
intraoperative urine output
Time frame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)
transfusion units
Time frame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first 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 29 Aug 2013.
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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 Avascular Necrosis of Hip, 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 2 inclusion and 5 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 29 Aug 2013. 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?
postoperative bleeding volume (time frame: at first postoperative day). The study lists 8 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 29 Aug 2013; AzTrials last refreshed its copy on 27 Oct 2026.