Femoral Neck Fractures
Conditions
Keywords
Hip Hemiarthroplasty, Tranexamic Acid, Topical, Blood Transfusion
Brief summary
This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.
Interventions
DRUGTranexamic Acid
DRUGPlacebo (saline)
Sponsors
Orthopedic Research and Education Foundation
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture
Exclusion criteria
* History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure * Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year * Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant * Patients with a known allergy to tranexamic acid * Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Needed Transfusions | From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay) | The rate of transfusion will be calculated for each study group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Pre/Post-operative Hemoglobin | Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level | — |
| Difference Between Pre/Post-operative Hematocrit | Pre-operative hematocrit level vs. post-operative day 1 hematocrit level | — |
| Inpatient Transfusion Amount | 2-4 days post-operative (length of inpatient hospital stay) | The transfusion amount will be calculated for each study group. |
| Number of Participants With Post-operative Complications | Admission to second post-operative visit (4-6 weeks post-operative) | — |
| Inpatient Hospitalization Cost | Collected 4-6 weeks post-operative | — |
| Length of Inpatient Hospital Stay | From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.
Tranexamic Acid | 17 |
| Placebo Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space.
Placebo (saline) | 19 |
| Total | 36 |
Baseline characteristics
| Characteristic | Total | Tranexamic Acid | Placebo |
|---|---|---|---|
| Age, Continuous | 83 years STANDARD_DEVIATION 9 | 83 years STANDARD_DEVIATION 8.6 | 83 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 36 Participants | 17 Participants | 19 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 | 36 Participants | 17 Participants | 19 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 36 participants | 17 participants | 19 participants |
| Sex: Female, Male Female | 31 Participants | 14 Participants | 17 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 19 |
| other Total, other adverse events | 6 / 17 | 11 / 19 |
| serious Total, serious adverse events | 1 / 17 | 2 / 19 |
Outcome results
Primary
Number of Participants Who Needed Transfusions
The rate of transfusion will be calculated for each study group.
Time frame: From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid | Number of Participants Who Needed Transfusions | 0 Participants |
| Placebo | Number of Participants Who Needed Transfusions | 5 Participants |
Secondary
Difference Between Pre/Post-operative Hematocrit
Time frame: Pre-operative hematocrit level vs. post-operative day 1 hematocrit level
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tranexamic Acid | Difference Between Pre/Post-operative Hematocrit | 4.1 percent of blood that is red blood cells |
| Placebo | Difference Between Pre/Post-operative Hematocrit | 4.4 percent of blood that is red blood cells |
Secondary
Difference Between Pre/Post-operative Hemoglobin
Time frame: Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tranexamic Acid | Difference Between Pre/Post-operative Hemoglobin | 1.45 grams per deciliter |
| Placebo | Difference Between Pre/Post-operative Hemoglobin | 1.48 grams per deciliter |
Secondary
Inpatient Hospitalization Cost
Time frame: Collected 4-6 weeks post-operative
Population: Data was not gathered for this outcome measure and therefore never analyzed.
Secondary
Inpatient Transfusion Amount
The transfusion amount will be calculated for each study group.
Time frame: 2-4 days post-operative (length of inpatient hospital stay)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid | Inpatient Transfusion Amount | NA unit of blood (250 cc) | — |
| Placebo | Inpatient Transfusion Amount | 1.2 unit of blood (250 cc) | Standard Deviation 0.45 |
Secondary
Length of Inpatient Hospital Stay
Time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid | Length of Inpatient Hospital Stay | 3.9 days | Standard Deviation 1.1 |
| Placebo | Length of Inpatient Hospital Stay | 4.8 days | Standard Deviation 1.9 |
Secondary
Number of Participants With Post-operative Complications
Time frame: Admission to second post-operative visit (4-6 weeks post-operative)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid | Number of Participants With Post-operative Complications | 6 Participants |
| Placebo | Number of Participants With Post-operative Complications | 11 Participants |