Osteoarthritis, Knee Clinical Trial
Official title:
Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty
NCT number | NCT01370460 |
Other study ID # | IRB 6669 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2011 |
Est. completion date | September 2012 |
Verified date | March 2023 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to assess postoperative blood loss and transfusion rates in total knee replacement after one-time administration of topical tranexamic acid.
Status | Completed |
Enrollment | 101 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System |
United States,
Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111. — View Citation
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | participants will be followed for the duration of hospital stay, an expected average of 3 days | |
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. | participants will be followed for the duration of hospital stay, an expected average of 3 days |
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