Blood Loss
Conditions
Keywords
Total hip arthroplasty, Total knee arthroplasty
Brief summary
This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).
Detailed description
Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions. In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients. Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted. Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.
Interventions
DRUGIntravenous Placebo
IV 0.9% sterile saline
DRUGIntravenous Tranexamic Acid
1g TXA IVPB (intravenous piggyback)
Sponsors
Winthrop University Hospital
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients 18 years and older who are already scheduled for primary total joint arthroplasty of the hip or knee
Exclusion criteria
for IV TXA administration * Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG) * If patient is on anticoagulant, patient must have documented approval from a cardiologist that patient can be removed from anticoagulant for total joint arthroplasty procedure * Renal impairment defined as serum Cr \> 1.5 or Cr Clearance \< 50 mL/min * Severe ischemic heart disease * Color blindness or problems with color vision Criteria for Use of Topical TXA * Topical TXA can be used in any patient meeting one of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Required a Blood Transfusion During Surgery | operative period (average of 1 hour) | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Levels of Hematocrit: Pre-operative to Post-operative | Day 3 or 4 post surgery | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. |
| Length of Hospital Stay | At Hospital Discharge | Measured in Days |
| Estimated Blood Loss During Surgery | Operative period (an average of 1 hour) | Surgeon estimated blood loss |
| Change in Hemoglobin: Pre-operative to Post-operative | Day 3 or 4 post surgery | Measured in grams/deciliter |
| Walking Distance Post Total Joint Arthroplasty of the Hip | 4 Days | Walking distance (feet) will be assessed and documented throughout the hospital stay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Tranexamic Acid * 1g TXA administered intravenous piggyback at start of surgery OR
* 1g TXA administered intravenous piggyback at start and at time of closure of surgery
Intravenous Tranexamic Acid: 1g TXA IVPB | 18 |
| Intravenous Placebo \- IV 0.9% sterile saline
Intravenous Placebo: IV 0.9% sterile saline | 20 |
| Intravenous Tranexamic Acid Followed by Intravenous Placebo * 1g TXA administered intravenous piggyback at start of surgery OR
* 1g TXA administered intravenous piggyback at start and at time of closure of surgery
* IV 0.9% sterile saline
Intravenous Placebo: IV 0.9% sterile saline
Intravenous Tranexamic Acid: 1g TXA IVPB | 14 |
| Total | 52 |
Baseline characteristics
| Characteristic | Intravenous Tranexamic Acid | Intravenous Placebo | Intravenous Tranexamic Acid Followed by Intravenous Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 6 | 67.2 years STANDARD_DEVIATION 11.4 | 65.2 years STANDARD_DEVIATION 12.3 | 65.6 years STANDARD_DEVIATION 10.1 |
| Pre-operative hematocrit | 43.6 percentage of red blood cells STANDARD_DEVIATION 4.6 | 41.2 percentage of red blood cells STANDARD_DEVIATION 4.2 | 41.2 percentage of red blood cells STANDARD_DEVIATION 4.3 | 42.0 percentage of red blood cells STANDARD_DEVIATION 4.5 |
| Pre-operative hemoglobin | 14.4 grams/decileter (g/dl) STANDARD_DEVIATION 1.5 | 13.6 grams/decileter (g/dl) STANDARD_DEVIATION 1.4 | 13.8 grams/decileter (g/dl) STANDARD_DEVIATION 1.5 | 13.9 grams/decileter (g/dl) STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 18 Participants | 12 Participants | 46 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 8 Participants | 29 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 6 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Who Required a Blood Transfusion During Surgery
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Time frame: operative period (average of 1 hour)
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Change in Hemoglobin: Pre-operative to Post-operative
Measured in grams/deciliter
Time frame: Day 3 or 4 post surgery
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Change in Levels of Hematocrit: Pre-operative to Post-operative
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Time frame: Day 3 or 4 post surgery
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Estimated Blood Loss During Surgery
Surgeon estimated blood loss
Time frame: Operative period (an average of 1 hour)
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Length of Hospital Stay
Measured in Days
Time frame: At Hospital Discharge
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Tranexamic Acid | Length of Hospital Stay | 3 Days |
| Intravenous Placebo | Length of Hospital Stay | 3 Days |
| Intravenous Tranexamic Acid Followed by Intravenous Placebo | Length of Hospital Stay | 3 Days |
Secondary
Walking Distance Post Total Joint Arthroplasty of the Hip
Walking distance (feet) will be assessed and documented throughout the hospital stay
Time frame: 4 Days
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.