Tranexamic Acid Study
| Status: | Withdrawn |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/21/2016 |
| Start Date: | February 2005 |
| End Date: | January 2008 |
Randomized Placebo Controlled Study Using Tranexamic Acid in Revision Total Hip Arthroplasty
The purpose of this study is to determine if tranexamic acid significantly reduces blood
loss and blood transfusion in revision total hip replacement. Tranexamic acid is a drug that
helps to reduce blood loss during surgery. Revision total hip replacement surgery is
treatment for patients who have previously had hipe replacement surgery which failed and
must be repaired/replaced.
loss and blood transfusion in revision total hip replacement. Tranexamic acid is a drug that
helps to reduce blood loss during surgery. Revision total hip replacement surgery is
treatment for patients who have previously had hipe replacement surgery which failed and
must be repaired/replaced.
Tranexamic acid is an anti-fibrinolytic agent that inhibits fibrinolysis leading to a
reduction of blood loss without concurrently increasing the risk of thromboembolic
complications. Several studies have shown that tranexamic acid reduces blood loss and blood
transfusions in primary total hip and knee arthroplasty. However, there have not been any
studies that evaluate its efficacy in revision total hip arthroplasty. The significance of
this study is that the need for blood transfusions and their complications may be minimized
in revision hip arthroplasty if tranexamic acid is found to significantly decrease the
amount of blood transfusions.
After the patient has been consented, he or she will be randomized into one of two groups
(tranexamic acid and placebo) by the School of Pharmacy. The placebo will be crystalloid
fluid of equal volume as tranexamic acid. The patient will then undergo revision total hip
arthroplasty by Dr. Rosenstein and be administered tranexamic acid or placebo. Blood loss
will be recorded intraoperatively and postoperatively through drains. Criteria for blood
transfusion include hemoglobin less than 10g/dl or hematocrit less than 30%. Once the
operation ends, the drug or placebo will be discontinued and the postoperative care is
unchanged from current standards/protocols. Intraoperative blood loss, total blood loss, and
number of blood transfusions will be recorded and analyzed. Length of acute hospital stay
will also be recorded. A cost analysis will be performed comparing tranexamic acid to blood
transfusions.
reduction of blood loss without concurrently increasing the risk of thromboembolic
complications. Several studies have shown that tranexamic acid reduces blood loss and blood
transfusions in primary total hip and knee arthroplasty. However, there have not been any
studies that evaluate its efficacy in revision total hip arthroplasty. The significance of
this study is that the need for blood transfusions and their complications may be minimized
in revision hip arthroplasty if tranexamic acid is found to significantly decrease the
amount of blood transfusions.
After the patient has been consented, he or she will be randomized into one of two groups
(tranexamic acid and placebo) by the School of Pharmacy. The placebo will be crystalloid
fluid of equal volume as tranexamic acid. The patient will then undergo revision total hip
arthroplasty by Dr. Rosenstein and be administered tranexamic acid or placebo. Blood loss
will be recorded intraoperatively and postoperatively through drains. Criteria for blood
transfusion include hemoglobin less than 10g/dl or hematocrit less than 30%. Once the
operation ends, the drug or placebo will be discontinued and the postoperative care is
unchanged from current standards/protocols. Intraoperative blood loss, total blood loss, and
number of blood transfusions will be recorded and analyzed. Length of acute hospital stay
will also be recorded. A cost analysis will be performed comparing tranexamic acid to blood
transfusions.
Inclusion Criteria:
- Failed primary total hip arthroplasty (femoral stem, acetabular component, or both)
- 18-100 years of age
Exclusion Criteria:
- Prosthetic infection
- Primary total hip arthroplasty
- Prisoners
- Pregnancy
- Previous adverse reaction to tranexamic acid
- Bleeding/coagulation disorders
- Renal insufficiency (serum creatinine>two standard deviations for age)
- History of deep venous thrombosis or pulmonary embolism
- Religious beliefs/practices prohibiting blood transfusions
- Wards of the state
- Cognitively impaired patients
- Terminally ill patients
- Students and/or employees
- Color blindness
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