Tranexamic Acid
DrugAdministration of 15 mg/kg intravenous Tranexamic Acid at the beginning of the surgical procedure/surgical pause
Other names: TEA
NCT Number: NCT07825350
The purpose of the study is to assess the effect of Tranexamic acid (TXa), a commonly used medication to prevent bleeding, in reducing blood loss during High Tibial Osteotomy (HTO). HTO is a common procedure aimed at realigning patients that are bow-legged, in an attempt to reduce pain associated with osteoarthritis of the knee, and to prevent its progression. A secondary aim is to assess the effect of TXa in preventing side-effects of surgery related to the healing of surgical wound.
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Interventional
Phase 3
Medial opening wedge high tibial osteotomy (MOW HTO) is an effective treatment of varus malalignment with associated medial compartment osteoarthritis, medial compartment osteochondral defect, and instability (1-3). Although this technique was developed to limit complications relative to its counterpart, the lateral closing wedge high tibial osteotomy, adverse events occur in up to 55% of cases. Martin et al stratified these adverse events and described the overall complication rate requiring further surgical management or long-term medical care to be 7%. Their stratification included 1) adverse events requiring no additional treatment such as delayed wound healing (6%) and hematoma (3%), 2) adverse events requiring extended non-operative management such as cellulitis (10%) and deep vein thrombosis (1%), and 3) adverse events requiring additional surgery such as deep infection (2%)(3).
There is emerging evidence that Tranexamic Acid (TEA) can safely and effectively decrease blood loss in patients undergoing HTO. Whilst rare, this may reduce the need for post-operative blood transfusions. There is also emerging evidence that TEA has a role in infection prevention in open reduction and internal fixation of traumatic fractures, as well as a decreased periprosthetic infection risk in hip and knee arthroplasty (4,5). This is thought to occur by indirect mechanisms such as the prevention of haematoma, but also direct mechanism through prevention of biofilm formation. There has not been a high-quality randomised controlled trial to demonstrate this effect however.
The Patient Observer Scar Assessment Scale (POSAS) is a widely used and validated clinical assessment tool that measures differences in wound-related outcomes(6). It is a sensitive measure of subtle changes in scar and wound healing due to treatment effect and can be used in addition to binary wound complication outcomes such as cellulitis, haematoma, purulence.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of 15 mg/kg intravenous Tranexamic Acid at the beginning of the surgical procedure/surgical pause
Other names: TEA
Standard of Care: routine medial opening wedge high tibial osteotomy
Other names: HTO
Time frame: Change between the patient's pre-operative blood draw (day of surgery) and that collected on day 1 post-operatively.
To prospectively evaluate the effect of tranexamic acid in reducing blood loss during High Tibial Osteotomy
Time frame: Pre-op (up to 6 months before surgery) , 2 & 6 weeks post -op, 3 & 6 months post-op
To determine the potential decrease in patient satisfaction following medial opening wedge high tibial osteotomy secondary to the administration of Tranexamic Acid.
Time frame: 2 & 6 weeks, 3 & 6 months post-op
To determine the potential benefit in wound healing
Time frame: pre-operatively (up to 6 months prior to surgery), post-op 2 & 6 weeks
To determine the potential decrease in post-operative complications, and patient satisfaction following medial opening wedge high tibial osteotomy secondary to the administration of Tranexamic Acid.
Time frame: 2 & 6 weeks post-op
To determine the potential decrease in post-operative complications, and patient satisfaction following medial opening wedge high tibial osteotomy secondary to the administration of Tranexamic Acid.
Contact information is provided by the study sponsor or research team.
Western University, Canada
Other
Efficacy of Tranexamic Acid in the Reduction of Postoperative Complications Following Medial Opening Wedge High Tibial Osteotomy
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