Hip Fractures
Conditions
Keywords
Blood, Transfusion, Hip, Fracture, Surgery, Replacement, Trauma
Brief summary
The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
Detailed description
A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population. Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions. The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.
Interventions
100 cc normal saline mixed with 1g of tranexamic acid in solution
OTHERPlacebo
100 cc normal saline
Sponsors
Lancaster General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All OR pharmacists are un-blinded to subject randomization.
Intervention model description
A prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of written informed consent 2. Age \> or = to 65 years 3. Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions 4. Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation
Exclusion criteria
1. Indication for closed reduction or percutaneous screw 2. Allergy to TXA 3. Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture 4. Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S & C deficiencies, prothrombin gene mutation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells. | 3 Months | Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | 3 Months | Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery. |
| Hospital Readmission | 30 Days | Determine differences between the groups in 30 day readmission rates. |
| Mortality Rate | 90 Days | Death within 90 days post hip surgery |
| Length of Stay | From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months. | Length of stay immediately post study intervention/surgery for hip fracture |
Countries
United States
Participant flow
Pre-assignment details
One participant was enrolled twice for separate hip fractures, so one of the enrollments was removed.
Participants by arm
| Arm | Count |
|---|---|
| Intervention 100 cc normal saline with 1g of tranexamic acid in solution
Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution | 146 |
| Placebo 100 cc normal saline
Placebo: 100 cc normal saline | 137 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 16 | 12 |
| Overall Study | Lost to Follow-up | 56 | 56 |
| Overall Study | Participant enrolled twice for separate hip fractures - one enrollment removed. | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Intervention | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 88.2 years STANDARD_DEVIATION 11 | 87.2 years STANDARD_DEVIATION 13 | 86.0 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 144 Participants | 280 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 142 Participants | 276 Participants | 134 Participants |
| Region of Enrollment United States | 146 participants | 283 participants | 137 participants |
| Sex: Female, Male Female | 105 Participants | 211 Participants | 106 Participants |
| Sex: Female, Male Male | 41 Participants | 72 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 146 | 12 / 137 |
| other Total, other adverse events | 69 / 146 | 57 / 137 |
| serious Total, serious adverse events | 3 / 146 | 1 / 137 |
Outcome results
Primary
Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.
Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.
Time frame: 3 Months
Population: All participants who underwent treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells. | 118 Participants |
| Placebo | Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells. | 111 Participants |
p-value: 0.96695% CI: [0.5597, 1.834]Regression, Logistic
Secondary
Complication Rate
Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery.
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Complication Rate | 43 Participants |
| Placebo | Complication Rate | 30 Participants |
p-value: 0.183Chi-squared
Secondary
Hospital Readmission
Determine differences between the groups in 30 day readmission rates.
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Hospital Readmission | 11 Participants |
| Placebo | Hospital Readmission | 8 Participants |
p-value: 0.729Chi-squared
Secondary
Length of Stay
Length of stay immediately post study intervention/surgery for hip fracture
Time frame: From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Length of Stay | 5 days | Standard Deviation 4.1 |
| Placebo | Length of Stay | 4.8 days | Standard Deviation 3.8 |
p-value: 0.7832t-test, 2 sided
Secondary
Mortality Rate
Death within 90 days post hip surgery
Time frame: 90 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Mortality Rate | 15 Participants |
| Placebo | Mortality Rate | 11 Participants |
p-value: 0.655Chi-squared