Status Post Total Hip and Knee ArthroplastyNCT02648295
Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty
An observational study of Status Post Total Hip and Knee Arthroplasty, run by West Virginia University.
Trial summary
Blood management is an important part of successful total joint replacement. Loss of blood and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has become a standard component to many blood management programs. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Status Post Total Hip and Knee Arthroplasty
- What is being tested?
- Effects of IV TXA on TEG in patients undergoing THA or TKA
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Oct 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults undergoing primary total hip and knee arthroplasty
Who may be able to join
- Primary total hip and knee arthroplasty patients presenting to WVU Center for Joint Replacement
- 40-90 years old
Who cannot join
- Known coagulopathy
- History of venothrombotic event
- Unstable angina
- Recent Myocardial infarction (MI)
- History of bleeding events
- History of chronic anemia
- Preoperative anemia
- Current use of blood thinners including aspirin
About this study
Blood management is an important part of successful total joint replacement. Loss of blood and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has become a standard component to many blood management programs. It is used to treat or prevent excessive blood loss during surgery and in various medical conditions such as excessive bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from growing and causing problems. When this process becomes overactive it can result in excessive bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the relationship between TXA and thromboelastogram (TEG) results.
- Being tested
- Effects of IV TXA on TEG in patients undergoing THA or TKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of IV TXA on TEG in patients undergoing THA or TKAProcedure or surgery
Subjects will undergo surgery per standard of care. All subjects will have 3 additional vials of blood drawn to evaluate TEG.
What is being measured
The primary outcome is the main question the study is designed to answer.
All time measurements which indicate various aspects of clotting cascade
Data derived from the TEG which includes R, MA, LY30 (R = clotting factors, MA clot strength and platelet function and LY30 is fibrinolysis).
Measured: 3 months
Secondary outcomes (1)
Blood loss and transfusions
Estimated and Calculated blood loss and transfusion requirements
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status Post Total Hip and Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Dietz, MD, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648295
- Sponsor's protocol ID
- 1509851949
- Status last verified
- Oct 2017
- First submitted
- 18 Dec 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02648295
- Acronym / sponsor ID
- 1509851949
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Jan 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.
Blood management is an important part of successful total joint replacement. Loss of blood and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has become a standard component to many blood management programs. It is used to treat or prevent excessive blood loss during surgery and in various medical conditions such as excessive bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from growing and causing problems. When this process becomes overactive it can result in excessive bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the relationship between TXA and thromboelastogram (TEG) results.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults undergoing primary total hip and knee arthroplasty
Key inclusion criteria (2 listed)
- Primary total hip and knee arthroplasty patients presenting to WVU Center for Joint Replacement
- 40-90 years old
Key exclusion criteria (8 listed)
- Known coagulopathy
- History of venothrombotic event
- Unstable angina
- Recent Myocardial infarction (MI)
- History of bleeding events
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 |
|---|---|---|
| Effects of IV TXA on TEG in patients undergoing THA or TKASubjects will undergo surgery per standard of care. All subjects will have 3 additional vials of blood drawn to evaluate TEG. | Procedure or surgery | – |
Primary outcome
All time measurements which indicate various aspects of clotting cascade
Time frame: 3 months
Data derived from the TEG which includes R, MA, LY30 (R = clotting factors, MA clot strength and platelet function and LY30 is fibrinolysis).
1 secondary outcome
Blood loss and transfusions
Time frame: 3 months
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 26 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Post Total Hip and Knee Arthroplasty, run by West Virginia University.
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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
All time measurements which indicate various aspects of clotting cascade (time frame: 3 months). 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 26 Oct 2017.