A Phase 2 interventional study of Tranexamic Acid and Placebo in Acute Blood Loss Anemia and Osteoarthritis, Knee, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Henry Ford Health System · Phase 2, Interventional, and Treatment
This study aims to assess postoperative blood loss and transfusion rates in total knee replacement after one-time administration of topical tranexamic acid.
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 101 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
Drug: Tranexamic Acid
100mL 0.9% NS, applied topically
Drug: Placebo
Topical tranexamic acid (2g/100mL 0.9% saline)
Also known as: Cyklokapron
100mL 0.9% sterile saline
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
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
| Milestone | Tranexamic Acid | Placebo |
|---|---|---|
| Started | 50 | 51 |
| Completed | 50 | 51 |
| Not completed | 0 | 0 |
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).
| mL | Placebo | Tranexamic Acid |
|---|---|---|
| Blood Loss | 1293.1 ± 532.7 | 940.2 ± 327.1 |
Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of \< 8.0g/dL hemoglobin, or any hemoglobin \<7.0 g/dL, precipitated transfusion.
| participants | Tranexamic Acid | Placebo |
|---|---|---|
| Postoperative Transfusion Rate | 0 | 4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events Not Collected | — | — | — |
| Age, Categorical(Participants) | Tranexamic Acid | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 26 | 51 |
| >=65 years | 25 | 25 | 50 |
| Age, Continuous(years) | Tranexamic Acid | Placebo | Total |
|---|---|---|---|
| Mean | 67 ± 9 | 64.5 ± 8.2 | 65.75 ± 8.6 |
| Sex: Female, Male(Participants) | Tranexamic Acid | Placebo | Total |
|---|---|---|---|
| Female | 31 | 39 | 70 |
| Male | 19 | 12 | 31 |
| Region of Enrollment(participants) | Tranexamic Acid | Placebo | Total |
|---|---|---|---|
| United States | 50 | 51 | 101 |
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Henry Ford Health System