Hip Fracture
Conditions
Keywords
Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture, Orthopaedic Trauma Association (OTA) fracture
Brief summary
Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.
Detailed description
Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid (TXA) is the best studied of these medications and a recent Cochrane Database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. At Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. Recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. A recent analysis of the Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. This raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.
Interventions
DRUGtranexamic acid
Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
DRUGplacebo
A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AO/OTA (Orthopedic Trauma Association) fracture classification 31B * Surgically treated with either hemiarthroplasty or total hip arthroplasty * Acute fracture treated within 72 hours of injury * Low energy isolated injury * Age greater than 18 years old
Exclusion criteria
* Transfusion received during admission, prior to surgery * Creatinine clearance less than 30 mL/min * History of unprovoked Venous Thromboembolism (VTE) and/or recurrent VTE * Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant * Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential) * History of cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within the previous 30 days * Coronary stent placement within the previous 6 months * Disseminated intravascular coagulation * Subarachnoid hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received a Hospitalization Transfusion | 5 days | Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calculated Blood Loss | 5 days | Calculated blood loss |
| Number of Participants With Venous Thromboembolism (VTE) Diagnosis | Within 6 months of surgery | Incidence of symptomatic VTE diagnosed within 6 months of surgery |
| Number of Participants With Wound Complications | Within 6 months of surgery | Wound complications diagnosed within 6 months of surgery |
| Mean Number of Units Transfused | 5 days | Mean number of units transfused per patient |
| Number of Participants With Cerebrovascular Accident (CVA) Diagnosis | Within 6 months of surgery | CVA diagnosed within 6 months of surgery |
| Number of Participants Who Died | 6 months after surgery | All-cause mortality at 6 months |
| Number of Participants With Myocardial Infarction (MI) Diagnosis | Within 6 months of surgery | MI diagnosed within 6 months of surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure. | 69 |
| Tranexamic Acid Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. | 69 |
| Total | 138 |
Baseline characteristics
| Characteristic | Placebo | Tranexamic Acid | Total |
|---|---|---|---|
| Age, Continuous | 82.2 years STANDARD_DEVIATION 10 | 81.0 years STANDARD_DEVIATION 10 | 81.6 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 69 participants | 69 participants | 138 participants |
| Sex: Female, Male Female | 47 Participants | 48 Participants | 95 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 69 | 15 / 69 |
| serious Total, serious adverse events | 15 / 69 | 14 / 69 |
Outcome results
Primary
Number of Participants Who Received a Hospitalization Transfusion
Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission
Time frame: 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Received a Hospitalization Transfusion | 18 participants |
| Tranexamic Acid | Number of Participants Who Received a Hospitalization Transfusion | 12 participants |
Secondary
Calculated Blood Loss
Calculated blood loss
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Calculated Blood Loss | 1214 cc | Standard Deviation 540 |
| Tranexamic Acid | Calculated Blood Loss | 902 cc | Standard Deviation 439 |
Secondary
Mean Number of Units Transfused
Mean number of units transfused per patient
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Number of Units Transfused | 1.8 units/participant transfused | Standard Deviation 0.9 |
| Tranexamic Acid | Mean Number of Units Transfused | 1.2 units/participant transfused | Standard Deviation 0.5 |
Secondary
Number of Participants Who Died
All-cause mortality at 6 months
Time frame: 6 months after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Died | 11 participants |
| Tranexamic Acid | Number of Participants Who Died | 10 participants |
p-value: 0.75Regression, Logistic
Secondary
Number of Participants With Cerebrovascular Accident (CVA) Diagnosis
CVA diagnosed within 6 months of surgery
Time frame: Within 6 months of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Cerebrovascular Accident (CVA) Diagnosis | 0 participants |
| Tranexamic Acid | Number of Participants With Cerebrovascular Accident (CVA) Diagnosis | 1 participants |
Secondary
Number of Participants With Myocardial Infarction (MI) Diagnosis
MI diagnosed within 6 months of surgery
Time frame: Within 6 months of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Myocardial Infarction (MI) Diagnosis | 3 participants |
| Tranexamic Acid | Number of Participants With Myocardial Infarction (MI) Diagnosis | 2 participants |
Secondary
Number of Participants With Venous Thromboembolism (VTE) Diagnosis
Incidence of symptomatic VTE diagnosed within 6 months of surgery
Time frame: Within 6 months of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Venous Thromboembolism (VTE) Diagnosis | 2 participants |
| Tranexamic Acid | Number of Participants With Venous Thromboembolism (VTE) Diagnosis | 3 participants |
Secondary
Number of Participants With Wound Complications
Wound complications diagnosed within 6 months of surgery
Time frame: Within 6 months of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Wound Complications | 2 participants |
| Tranexamic Acid | Number of Participants With Wound Complications | 5 participants |