Phase 4
Completed N=127
Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)
Blood Loss
Source: ClinicalTrials.gov NCT02374398 ↗
Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: The Change in Hemoglobin (Hb) From the Day of Surgery — 2.6; 3.2; 2.6; 3.7 g/dl
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The assumption is that the combination of iv TXA and Aquamantys system will enable an improvement in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated by the use of Aquamantys system alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Hemoglobin (Hb) From the Day of Surgery |
2.6; 3.2; 2.6; 3.7 | — |
| PRIMARY The Change in Hematocrit (Ht) From the Day of Surgery |
7.1; 8.6; 6.8; 10.0 | — |
| SECONDARY Post Operative Blood Loss |
747.9; 938.9; 746.6; 1077.6 | — |
| SECONDARY Cost Analysis |
NA; NA; NA; NA | — |
| SECONDARY Adverse Events |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients over age of 18 undergoing elective total primary knee arthroplasty under spinal anesthesia.
Exclusion Criteria
- Previous adverse reaction to tranexamic acid
- Congenital or acquired coagulation disorders
- Preoperative platelet count of less than 100,000/microliter or INR> 1.4
- History of deep venous thrombosis, pulmonary embolism or cerebrovascular accident
- Patients with acquired defective color vision
- Renal insufficiency (Glomerular filtration rate <20 ml/min)
- Severe liver disease
- Coronary stents
- Pregnant patients
- Main anesthetic other than spinal anesthesia
Data sourced from ClinicalTrials.gov (NCT02374398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.