Avascular Necrosis of HipNCT01512628
Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty
A study testing Pentaspan, voluven, volulyte in people with Avascular Necrosis of Hip and Total Hip Replacement Arthroplasty, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators administered different kinds of colloids before transfusion of red blood cell to patient undergoing total hip replacement arthroplasty. The investigators will compare the differences of changes in rotational thromboelastometry (ROTEM) data among them. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Avascular Necrosis of Hip, Total Hip Replacement Arthroplasty
- What is being tested?
- Pentaspan, voluven, volulyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as avascular necrosis of hip and undergoing total hip replacement arthroplasty
Who cannot join
- hematologic disease
- anticoagulant medication
- preoperative hemoglobin < 10 g/dl
- renal disease
- pulmonary disease (pulmonary edema, effusion)
- cardiovascular disease (coronary heart disease, congestive heart failure)
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: Hemostatic Changes After Colloid Fluid Administration During Total Hip Replacement Arthroplasty
The investigators administered different kinds of colloids before transfusion of red blood cell to patient undergoing total hip replacement arthroplasty. The investigators will compare the differences of changes in rotational thromboelastometry (ROTEM) data among them.
- Being tested
- Pentaspan, voluven, volulyte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentaspan, voluven, volulyteDrug
Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.
| Study group | Role | What they receive |
|---|---|---|
| PENTA group | Active comparator | Pentaspan is administered as a colloid. Receives: Drug: Pentaspan, voluven, volulyte |
| voluVEN group | Active comparator | Voluven is administered as a colloid. Receives: Drug: Pentaspan, voluven, volulyte |
| voluLYTE group | Active comparator | Volulyte is administered as a colloid. Receives: Drug: Pentaspan, voluven, volulyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
INTEM parameters change from preoperative values at post-operation
clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)
Measured: 30 minutes before operation and 30 minutes after operation
EXTEM parameters change from preoperative values at post-operation
clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)
Measured: 30 minutes before and 30 minutes after operation.
FIBTEM parameters change from preoperative values at post-operation
maximum clot firmness (mm)
Measured: 30 min before and 30 min after operation
Secondary outcomes (8)
Infused total fluid volume
crystalloid and colloid
Measured: Participants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hours
Hemoglobin
Measured: 30 minutes before operation and 30 minutes after operation
postoperative blood loss
Measured: postoperative 1 day and 2 day
Hematocrit
Measured: 30 minutes before operation and 30 minutes after operation
Platelet
Measured: 30 minutes before operation and 30 minutes after operation
Prothrombin Time-Internatiolnal Normalized Ratio
Measured: 30 minutes before operation and 30 minutes after operation
Activated Partial Thrombin Time
Measured: 30 minutes before operation and 30 minutes after operation
electrolytes
Measured: 30 minutes before operation and 30 minutes after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT01512628
- Sponsor's protocol ID
- B1111-140-010
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2012
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Changes After Colloid Fluid Administration During Total Hip Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT01512628
- Acronym / sponsor ID
- B1111-140-010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 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.
The investigators administered different kinds of colloids before transfusion of red blood cell to patient undergoing total hip replacement arthroplasty. The investigators will compare the differences of changes in rotational thromboelastometry (ROTEM) data among them.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PENTA group | Active comparator | Drug: Pentaspan, voluven, volulytePentaspan is administered as a colloid. |
| voluVEN group | Active comparator | Drug: Pentaspan, voluven, volulyteVoluven is administered as a colloid. |
| voluLYTE group | Active comparator | Drug: Pentaspan, voluven, volulyteVolulyte is administered as a colloid. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed as avascular necrosis of hip and undergoing total hip replacement arthroplasty
Key exclusion criteria (6 listed)
- hematologic disease
- anticoagulant medication
- preoperative hemoglobin < 10 g/dl
- renal disease
- pulmonary disease (pulmonary edema, effusion)
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 |
|---|---|---|
| Pentaspan, voluven, volulyteDifferent colloids are administered during operation for replacement of blood loss before the transfusion of blood. | Drug | PENTA group, voluLYTE group, voluVEN group |
Primary outcome
INTEM parameters change from preoperative values at post-operation
Time frame: 30 minutes before operation and 30 minutes after operation
clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)
EXTEM parameters change from preoperative values at post-operation
Time frame: 30 minutes before and 30 minutes after operation.
clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)
FIBTEM parameters change from preoperative values at post-operation
Time frame: 30 min before and 30 min after operation
maximum clot firmness (mm)
8 secondary outcomes
Infused total fluid volume
Time frame: Participants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hours
Hemoglobin
Time frame: 30 minutes before operation and 30 minutes after operation
postoperative blood loss
Time frame: postoperative 1 day and 2 day
Hematocrit
Time frame: 30 minutes before operation and 30 minutes after operation
Platelet
Time frame: 30 minutes before operation and 30 minutes after operation
Prothrombin Time-Internatiolnal Normalized Ratio
Time frame: 30 minutes before operation and 30 minutes after operation
Activated Partial Thrombin Time
Time frame: 30 minutes before operation and 30 minutes after operation
electrolytes
Time frame: 30 minutes before operation and 30 minutes after operation
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 28 Jan 2014.
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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 Pentaspan, voluven, volulyte in people with Avascular Necrosis of Hip and Total Hip Replacement Arthroplasty, 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 6 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 28 Jan 2014. 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?
INTEM parameters change from preoperative values at post-operation (time frame: 30 minutes before operation and 30 minutes after operation). The study lists 3 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 28 Jan 2014.