Postoperative HemorrhageNCT02963623
Fibtem Predicts Postoperative Bleeding
An observational study of Postoperative Hemorrhage, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in total knee replacement patients. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Postoperative Hemorrhage
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Sep 2017
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: total knee replacement patients
Who may be able to join
- patients who underwent primany unilateral total knee replacement arthroplasty under general anesthesia
- patients who had FIBTEM performed
Who cannot join
- surgery under regional anaesthesia
- a simultaneous bilateral total knee replacement arthroplasty
- the second surgery of staged total knee replacement arthroplasty
- revision of total knee replacement arthroplasty
- patients who received intraoperative transfusion
- patients who use tranexamic acid
- patients who received fibrinolytic agents because of perioperative thromboembolic event
- patients who refused transfusion because of religious belief of personal causes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prediction of Postoperative Hemorrahge Amount in Total Knee Replacement Using Fibtem
Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in total knee replacement patients.
Read the detailed description
This retrospective study evaluate patients who underwent total knee replacement arthroplasty. Laboratory coagulation parameters, including FIBTEM, before anesthesia induction and after admission to the post-anesthetic care unit and decrement of postoperative haemoglobin and amount of transfusion were reviewed.
A correlation coefficient of ρ = 0.4 was calculated from a pilot study. We need at least 44 subjects with an α value of 0.05 and a power of 0.8.
- Conditions
- Postoperative Hemorrhage
- Keywords
- fibtem, total knee replacement
- Medical subject headings
- Postoperative Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
haemoglobin
the decrement of haemoglobin
Measured: postoperative periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HemorrhageStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ka Young Rhee, Konkuk University Medical Center
- Investigators
- Ka Young LRhee, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963623
- Sponsor's protocol ID
- KUH1160104
- Status last verified
- Mar 2018
- First submitted
- 9 Nov 2016
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction of Postoperative Hemorrahge Amount in Total Knee Replacement Using Fibtem
- ClinicalTrials.gov ID
- NCT02963623
- Acronym / sponsor ID
- KUH1160104
- Conditions
- Postoperative Hemorrhage
- Keywords
- fibtem, total knee replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 15 Nov 2016 (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.
Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in total knee replacement patients.
Detailed description
This retrospective study evaluate patients who underwent total knee replacement arthroplasty. Laboratory coagulation parameters, including FIBTEM, before anesthesia induction and after admission to the post-anesthetic care unit and decrement of postoperative haemoglobin and amount of transfusion were reviewed.
A correlation coefficient of ρ = 0.4 was calculated from a pilot study. We need at least 44 subjects with an α value of 0.05 and a power of 0.8.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- total knee replacement patients
Key inclusion criteria (2 listed)
- patients who underwent primany unilateral total knee replacement arthroplasty under general anesthesia
- patients who had FIBTEM performed
Key exclusion criteria (8 listed)
- surgery under regional anaesthesia
- a simultaneous bilateral total knee replacement arthroplasty
- the second surgery of staged total knee replacement arthroplasty
- revision of total knee replacement arthroplasty
- patients who received intraoperative transfusion
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
haemoglobin
Time frame: postoperative periods
the decrement of haemoglobin
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 9 Mar 2018.
- Individual participant dataSharing planned: Yes
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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.
Ka Young LRhee principal investigator
Konkuk University Medical Center
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 Postoperative Hemorrhage, run by Konkuk University Medical Center 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 8 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 9 Mar 2018. 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?
haemoglobin (time frame: postoperative periods). 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 9 Mar 2018.