Blood LossNCT02080494
Tranexamic Acid in Orthopaedic Trauma Surgery
A study testing Tranexamic Acid in people with Blood Loss and Trauma, run by University of Tennessee at 1 site in United States.
Trial summary
Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (>300mL) is expected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Trauma, Fracture
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with isolated fractures of the pelvic ring, acetabulum, femur or tibia that will require open reduction and internal fixation
- Expected blood loss is greater than 300 mL
- Age ≥ 18
- Skeletal maturity
Who cannot join
- Pregnant or breastfeeding
- Patients taking oral contraceptives
- Contraindication to venous thromboembolic event (VTE) prophylaxis (intracranial, intrathoracic, intra-abdominal bleeding or spine fractures)
- Patients requiring operative intervention for other injuries (orthopaedic or non-orthopaedic)
- Known hypercoagulable state including history of prescribed anti-coagulation (warfarin, plavix, low molecular weight heparin)
- Renal Insufficiency (creatinine greater than 1.5mg/dL)
- Open fractures
Trial locations and contacts
1 site in 1 country.
United States1 site
Erlanger Health System
Chattanooga, Tennessee, 37403
About this study
Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (>300mL) is expected.
The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.
- Conditions
- Blood Loss, Trauma, Fracture, Surgery
- Being tested
- Tranexamic Acid
- Keywords
- tranexamic acid, orthopaedic trauma, pelvic fracture, hip fracture, femur fracture, blood loss
- Medical subject headings
- Hemorrhage, Wounds and Injuries, Fractures, Bone, Hip Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No tranexamic acid given |
| Tranexamic Acid | Experimental | 15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin value
Measured: through postoperative day four
Secondary outcomes (2)
hematocrit value
Measured: through postoperative day four
number of units of allogenic blood transfused
Measured: through postoperative day four
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMay 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk W Kiner, MD, Principal investigator, UTCOM Chattanooga / Erlanger Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080494
- Sponsor's protocol ID
- 11-036
- Status last verified
- May 2018
- First submitted
- 8 Jan 2014
- Last updated
- 11 Jul 2018
- 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 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Orthopaedic Trauma Surgery
- ClinicalTrials.gov ID
- NCT02080494
- Acronym / sponsor ID
- 11-036
- Conditions
- Blood Loss, Trauma, Fracture, Surgery
- Keywords
- tranexamic acid, orthopaedic trauma, pelvic fracture, hip fracture, femur fracture, blood loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Mar 2014 (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.
Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (>300mL) is expected.
The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No tranexamic acid given |
| Tranexamic Acid | Experimental | Drug: Tranexamic Acid15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with isolated fractures of the pelvic ring, acetabulum, femur or tibia that will require open reduction and internal fixation
- Expected blood loss is greater than 300 mL
- Age ≥ 18
- Skeletal maturity
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding
- Patients taking oral contraceptives
- Contraindication to venous thromboembolic event (VTE) prophylaxis (intracranial, intrathoracic, intra-abdominal bleeding or spine fractures)
- Patients requiring operative intervention for other injuries (orthopaedic or non-orthopaedic)
- Known hypercoagulable state including history of prescribed anti-coagulation (warfarin, plavix, low molecular weight heparin)
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 |
|---|---|---|
| Tranexamic Acid | Drug | Tranexamic Acid |
Primary outcome
hemoglobin value
Time frame: through postoperative day four
2 secondary outcomes
hematocrit value
Time frame: through postoperative day four
number of units of allogenic blood transfused
Time frame: through postoperative day four
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Dirk W Kiner, MD principal investigator
UTCOM Chattanooga / Erlanger Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid in people with Blood Loss and Trauma, run by University of Tennessee 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Jul 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 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?
Results are not available in the source record.
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 value (time frame: through postoperative day four). 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 11 Jul 2018.