Tranexamic Acid UseNCT02989155
Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty
An observational study of Tranexamic Acid Use and Blood Loss, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to determine the need for a blood transfusion during surgery and to evaluate the levels of certain proteins in the blood when given tranexamic acid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tranexamic Acid Use, Blood Loss
- How many people
- 576 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Four surgeons providing total hip replacement services within the date range for data collection have formally agreed to include their patients in the study population, therefore identification of patients will occur through screening the surgery log of each surgeon performing these surgeries within the defined date range.
Who may be able to join
- Adult patients 18 years of age and older
- Surgical patients who underwent primary total hip arthroplasty (THA)
- Surgical patients who underwent revision THA
- Preoperative hemoglobin values (N) 11 g/dl
- Normal international normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT) values
Who cannot join
- - Allergy to tranexamic acid
- Bilateral THA
- History of ischemic heart disease
- Severe chronic heart failure
- Hepatic dysfunction
- Chronic renal failure
Show all 12Show fewer
- On hemodialysis
- Cerebral infarction
- History of seizure
- Bleeding disorder
- Anticoagulant or aspirin-like medication and long acting NSAID medication
- Short acting NSAID's were discontinued at least 24 hrs before surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
The purpose of this study is to determine the need for a blood transfusion during surgery and to evaluate the levels of certain proteins in the blood when given tranexamic acid.
Read the detailed description
A review of the medical record between January 01 2013 to July 1st 2015 will be used to determine if the hypothesis that patients receiving tranexamic acid will have a lower need for blood transfusion and there are changes in the levels of the proteins essential for healthy oxygen transport throughout the body is correct. Tranexamic acid is a medication which may help wounds to stop bleeding more quickly. Participants are not expected to receive any direct benefits from participating in this study. Only a small risk of private patient medical information being exposed is anticipated. The results of this study will help surgeons and the medical community to better understand the uses of this type of drug and its possible role in benefiting hip replacement patients during and following surgery.
- Conditions
- Tranexamic Acid Use, Blood Loss
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin, hematocrit, and red blood cell transfusion rates
Whether intraoperative dose of 2gr tranexamic acid (TXA) in patients having primary or revision THA would decrease the perioperative and post-operative reduction in hemoglobin, hematocrit, and red blood cell transfusion rates compared with those of a similar group of patients who did not receive TXA (control group).
Measured: Peri-operative care
Secondary outcomes (1)
clinically-significant venous thromboembolism (VTE) and all-cause mortality
frequency of clinically-significant venous thromboembolism (VTE) and all-cause mortality within 30 days of surgery
Measured: within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tranexamic Acid UseStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicoleta Stoicea, Ohio State University
- Investigators
- Nicoleta Stoicea, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989155
- Sponsor's protocol ID
- 2015H0427
- Status last verified
- Jan 2017
- First submitted
- 8 Dec 2016
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02989155
- Acronym / sponsor ID
- 2015H0427
- Conditions
- Tranexamic Acid Use, Blood Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Dec 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.
The purpose of this study is to determine the need for a blood transfusion during surgery and to evaluate the levels of certain proteins in the blood when given tranexamic acid.
Detailed description
A review of the medical record between January 01 2013 to July 1st 2015 will be used to determine if the hypothesis that patients receiving tranexamic acid will have a lower need for blood transfusion and there are changes in the levels of the proteins essential for healthy oxygen transport throughout the body is correct. Tranexamic acid is a medication which may help wounds to stop bleeding more quickly. Participants are not expected to receive any direct benefits from participating in this study. Only a small risk of private patient medical information being exposed is anticipated. The results of this study will help surgeons and the medical community to better understand the uses of this type of drug and its possible role in benefiting hip replacement patients during and following surgery.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Four surgeons providing total hip replacement services within the date range for data collection have formally agreed to include their patients in the study population, therefore identification of patients will occur through screening the surgery log of each surgeon performing these surgeries within the defined date range.
Key inclusion criteria (5 listed)
- Adult patients 18 years of age and older
- Surgical patients who underwent primary total hip arthroplasty (THA)
- Surgical patients who underwent revision THA
- Preoperative hemoglobin values (N) 11 g/dl
- Normal international normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT) values
Key exclusion criteria (12 listed)
- - Allergy to tranexamic acid
- Bilateral THA
- History of ischemic heart disease
- Severe chronic heart failure
- Hepatic dysfunction
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
hemoglobin, hematocrit, and red blood cell transfusion rates
Time frame: Peri-operative care
Whether intraoperative dose of 2gr tranexamic acid (TXA) in patients having primary or revision THA would decrease the perioperative and post-operative reduction in hemoglobin, hematocrit, and red blood cell transfusion rates compared with those of a similar group of patients who did not receive TXA (control group).
1 secondary outcome
clinically-significant venous thromboembolism (VTE) and all-cause mortality
Time frame: within 30 days of surgery
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 20 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Tranexamic Acid Use
Not yet recruitingPhase 2
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement.
Ankle Arthritis, Wound Complication
Not yet recruitingPhase 4
Oral Tranexamic Acid After Total Knee Arthroplasty
Total Knee Arthroplasty
Not yet recruitingPhase 3
Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy
Cerebral Palsy, Hip Surgery Corrective
Active, not recruitingEarly Phase 1
Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery
Pelvic Mass
Active, not recruitingObservational study
Prospective Investigation of Intra-Articular Tranexamic Acid Use in Elective Hip Arthroplasty
Blood Loss, Hemoglobin Change
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.
Nicoleta Stoicea, MD, PhD principal investigator
Ohio State University
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 Tranexamic Acid Use and Blood Loss, run by Ohio State University at 1 site in United States.
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 5 inclusion and 12 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 20 Jan 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 United States. 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?
hemoglobin, hematocrit, and red blood cell transfusion rates (time frame: Peri-operative care). 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 20 Jan 2017.