Hip FracturesPhase 4NCT02580227
Tranexamic Acid in Intertrochanteric and Subtrochanteric Femur Fractures
A Phase 4 study testing Tranexamic Acid in people with Hip Fractures and Surgical Blood Loss, run by Good Samaritan Regional Medical Center, Oregon at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Surgical Blood Loss
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Mar 2017
- Phase
- Phase 4
- 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 sustaining a closed intertrochanteric femur fracture presenting to the Good Samaritan Regional Medical Center.
- Patients who are willing and able to consent to participate in the study
- >18 years of age
Who cannot join
- Patients with an allergy to tranexamic acid.
- History of thromboembolic event (pulmonary embolism, cerebral vascular accident, deep venous thrombosis),
- History of renal impairment (Cr > 1.5 or glomerular filtration rate < 30)
- Coronary stents
- History of hypercoagulability (Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant).
- Color blindness
- Subarachnoid hemorrhage
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330
Stefan Yakel, DO, 541-768-4810, styakel@samhealth.org
Shawn Spooner, BA, 541-768-6349, sspooner@samhealth.org
About this study
Official title: The Effect of Preoperative Tranexamic Acid on Blood Loss and Transfusion Rates in Intertrochanteric and Subtrochanteric Femur Fractures.
The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our hypothesis is that by providing TXA at the time of hospital admission it will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in which half of patients will be randomized to receive TXA at the time of hospital admission and half of patients will receive a placebo.
Read the detailed description
Tranexamic Acid has a long and proven history of clinical safety and effectiveness in the Orthopaedic literature. Its use in perioperative blood management in total joint arthroplasty is wide spread and is quickly becoming a standard of care. However, evidence on the effectiveness of TXA in lower extremity fracture care is more limited. There is a logical expectation that the use of TXA in lower extremity fracture care will provide a similar benefit in minimizing blood loss and reducing transfusion requirements, based on TXA's success in total joint arthroplasty, however this has not yet been validated in the literature. This study will seek to evaluate the effectiveness of TXA in perioperative blood management within a subset of lower extremity fracture, specifically intertrochanteric femur fractures. Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications. Intertrochanteric femur fractures have an increased risk of post-operative blood transfusion when compared to femoral neck fractures. It is presumed that the difference in blood loss between these two fracture types is caused by increased pre-operative bleeding of intertrochanteric fractures secondary to the extracapsular nature of the fracture, as opposed to a tamponade effect that occurs with intracapsular femoral neck fractures. It can therefore be expected that the use of TXA in intertrochanteric femur fractures will decrease perioperative bleeding leading to a decrease in total blood loss and a decrease in transfusion rates.
Limited research has shown that TXA is effective in reducing perioperative blood loss in hip fracture when compared to placebo, but not as effectively as when used in joint arthroplasty. One explanation for this difference is that TXA is circulating at the time of iatrogenic fracture in total joint arthroplasty or given shortly after, whereas intraoperative TXA administration in hip fractures usually doesn't occur until 6-48 hours after the initial injury. Administering TXA at the time of hospital admission in intertrochanteric femur fracture allows the drug time to decrease blood loss resulting from the fracture as well as the subsequent surgical intervention.
- Conditions
- Hip Fractures, Surgical Blood Loss
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- Tranexamic Acid, Blood Transfusions
- Medical subject headings
- Hip Fractures, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.
PlaceboOther
All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Active comparator | Patients will be randomized 1:1 onto active TXA arm, or placebo arm. Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Patients will be randomized 1:1 onto active TXA arm, or placebo arm. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Blood Loss
Perioperative blood loss measured by serial hemoglobin and hematocrit
Measured: Admission to discharge, 3-4 days on average.
Blood Transfusion Rates
Measured: Admission to discharge, 3-4 days on average.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Good Samaritan Regional Medical Center, Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Yakel, Good Samaritan Regional Medical Center, Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580227
- Sponsor's protocol ID
- 15-021
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Desai SJ, Wood KS, Marsh J, Bryant D, Abdo H, Lawendy AR, Sanders DW. Factors affecting transfusion requirement after hip fracture: can we reduce the need for blood? Can J Surg. 2014 Oct;57(5):342-8. doi: 10.1503/cjs.030413.
PubMed 25265109Kadar A, Chechik O, Steinberg E, Reider E, Sternheim A. Predicting the need for blood transfusion in patients with hip fractures. Int Orthop. 2013 Apr;37(4):693-700. doi: 10.1007/s00264-013-1795-7. Epub 2013 Feb 5.
PubMed 23381612Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.
PubMed 19926634Vijay BS, Bedi V, Mitra S, Das B. Role of tranexamic acid in reducing postoperative blood loss and transfusion requirement in patients undergoing hip and femoral surgeries. Saudi J Anaesth. 2013 Jan;7(1):29-32. doi: 10.4103/1658-354X.109803.
PubMed 23717228
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Tranexamic Acid on Blood Loss and Transfusion Rates in Intertrochanteric and Subtrochanteric Femur Fractures.
- ClinicalTrials.gov ID
- NCT02580227
- Acronym / sponsor ID
- 15-021
- Conditions
- Hip Fractures, Surgical Blood Loss
- Keywords
- Tranexamic Acid, Blood Transfusions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Good Samaritan Regional Medical Center, OregonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 20 Oct 2015 (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 objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our hypothesis is that by providing TXA at the time of hospital admission it will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in which half of patients will be randomized to receive TXA at the time of hospital admission and half of patients will receive a placebo.
Detailed description
Tranexamic Acid has a long and proven history of clinical safety and effectiveness in the Orthopaedic literature. Its use in perioperative blood management in total joint arthroplasty is wide spread and is quickly becoming a standard of care. However, evidence on the effectiveness of TXA in lower extremity fracture care is more limited. There is a logical expectation that the use of TXA in lower extremity fracture care will provide a similar benefit in minimizing blood loss and reducing transfusion requirements, based on TXA's success in total joint arthroplasty, however this has not yet been validated in the literature. This study will seek to evaluate the effectiveness of TXA in perioperative blood management within a subset of lower extremity fracture, specifically intertrochanteric femur fractures. Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications. Intertrochanteric femur fractures have an increased risk of post-operative blood transfusion when compared to femoral neck fractures. It is presumed that the difference in blood loss between these two fracture types is caused by increased pre-operative bleeding of intertrochanteric fractures secondary to the extracapsular nature of the fracture, as opposed to a tamponade effect that occurs with intracapsular femoral neck fractures. It can therefore be expected that the use of TXA in intertrochanteric femur fractures will decrease perioperative bleeding leading to a decrease in total blood loss and a decrease in transfusion rates.
Limited research has shown that TXA is effective in reducing perioperative blood loss in hip fracture when compared to placebo, but not as effectively as when used in joint arthroplasty. One explanation for this difference is that TXA is circulating at the time of iatrogenic fracture in total joint arthroplasty or given shortly after, whereas intraoperative TXA administration in hip fractures usually doesn't occur until 6-48 hours after the initial injury. Administering TXA at the time of hospital admission in intertrochanteric femur fracture allows the drug time to decrease blood loss resulting from the fracture as well as the subsequent surgical intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Active comparator | Drug: Tranexamic AcidPatients will be randomized 1:1 onto active TXA arm, or placebo arm. |
| Placebo | Placebo comparator | Other: PlaceboPatients will be randomized 1:1 onto active TXA arm, or placebo arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients sustaining a closed intertrochanteric femur fracture presenting to the Good Samaritan Regional Medical Center.
- Patients who are willing and able to consent to participate in the study
- >18 years of age
Key exclusion criteria (7 listed)
- Patients with an allergy to tranexamic acid.
- History of thromboembolic event (pulmonary embolism, cerebral vascular accident, deep venous thrombosis),
- History of renal impairment (Cr > 1.5 or glomerular filtration rate < 30)
- Coronary stents
- History of hypercoagulability (Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant).
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 AcidAll subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given. | Drug | Tranexamic Acid |
| PlaceboAll subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given. | Other | Placebo |
Primary outcome
Perioperative Blood Loss
Time frame: Admission to discharge, 3-4 days on average.
Perioperative blood loss measured by serial hemoglobin and hematocrit
Blood Transfusion Rates
Time frame: Admission to discharge, 3-4 days on average.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Results publication: PubMed 25265109Desai SJ, Wood KS, Marsh J, Bryant D, Abdo H, Lawendy AR, Sanders DW. Factors affecting transfusion requirement after hip fracture: can we reduce the need for blood? Can J Surg. 2014 Oct;57(5):342-8. doi: 10.1503/cjs.030413.
- Results publication: PubMed 23381612Kadar A, Chechik O, Steinberg E, Reider E, Sternheim A. Predicting the need for blood transfusion in patients with hip fractures. Int Orthop. 2013 Apr;37(4):693-700. doi: 10.1007/s00264-013-1795-7. Epub 2013 Feb 5.
- Results publication: PubMed 19926634Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.
- Results publication: PubMed 23717228Vijay BS, Bedi V, Mitra S, Das B. Role of tranexamic acid in reducing postoperative blood loss and transfusion requirement in patients undergoing hip and femoral surgeries. Saudi J Anaesth. 2013 Jan;7(1):29-32. doi: 10.4103/1658-354X.109803.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid in people with Hip Fractures and Surgical Blood Loss, run by Good Samaritan Regional Medical Center, Oregon 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 3 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 29 Oct 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Stefan Yakel, DO (541-768-4810, styakel@samhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Blood Loss (time frame: Admission to discharge, 3-4 days on average.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580227, which also lists 4 linked publications.
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 29 Oct 2015.