Acute Blood Loss Anemia, Osteoarthritis, Knee
Conditions
Keywords
Tranexamic Acid, Blood transfusion, Total knee arthroplasty
Brief summary
This study aims to assess postoperative blood loss and transfusion rates in total knee replacement after one-time administration of topical tranexamic acid.
Detailed description
Autologous (donor) blood transfusion is an expensive and common occurrence after total knee replacement. Published data puts this rate between 9 and 40% after primary unilateral total knee arthroplasty. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called minimally- invasive techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total knee replacement, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total knee arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. Furthermore, the one aforementioned randomized clinical trial used a variety of postoperative deep vein thrombosis prophylaxis after surgery and introduced a potential confounding variable. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.
Interventions
DRUGTranexamic Acid
Topical tranexamic acid (2g/100mL 0.9% saline)
DRUGPlacebo
100mL 0.9% sterile saline
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients over age eighteen * Primary unilateral total knee arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)
Exclusion criteria
* patient history of venous thromboembolic disease or coagulopathy * use of anticoagulant medications within 7 days of surgery * history of arterial embolic disease * history of Class III or IV heart failure * renal failure * intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI, intraoperative fracture, vasopressor support, emergent intubation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | participants will be followed for the duration of hospital stay, an expected average of 3 days | Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Transfusion Rate | participants will be followed for the duration of hospital stay, an expected average of 3 days | Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of \< 8.0g/dL hemoglobin, or any hemoglobin \<7.0 g/dL, precipitated transfusion. |
Countries
United States
Participant flow
Pre-assignment details
We planned on 50 patients in one treatment arm and 51 in another, resulting in 101 overall patients.
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty. | 50 |
| Placebo 100mL 0.9% NS, applied topically | 51 |
| Total | 101 |
Baseline characteristics
| Characteristic | Placebo | Tranexamic Acid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 25 Participants | 51 Participants |
| Age, Continuous | 64.5 years STANDARD_DEVIATION 8.2 | 67 years STANDARD_DEVIATION 9 | 65.75 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United States | 51 participants | 50 participants | 101 participants |
| Sex: Female, Male Female | 39 Participants | 31 Participants | 70 Participants |
| Sex: Female, Male Male | 12 Participants | 19 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Blood Loss
Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146).
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Blood Loss | 1293.1 mL | Standard Deviation 532.7 |
| Tranexamic Acid | Blood Loss | 940.2 mL | Standard Deviation 327.1 |
Secondary
Postoperative Transfusion Rate
Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of \< 8.0g/dL hemoglobin, or any hemoglobin \<7.0 g/dL, precipitated transfusion.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Postoperative Transfusion Rate | 0 participants |
| Tranexamic Acid | Postoperative Transfusion Rate | 4 participants |