Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Tranexamic Acid
- Conditions
- Blood Loss
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total estimated blood loss
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.
Detailed Description
Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement. In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.
Investigators
Christian Skovgaard Nielsen
MD
Hvidovre University Hospital
Eligibility Criteria
Inclusion Criteria
- •\> 18 years old
- •Unilateral knee replacement
- •Must be able to give oral and written consent
Exclusion Criteria
- •General Anesthetized
- •Allergic to Tranexamic acid
- •In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor.
- •Use of oral anticonceptive.
- •Reduced kidney function (S-creatinine \> 120 micromol/L)
- •Medicine or alcohol abuse
- •Females with menstruation within the last 12 mounts.
- •Any kind of cancer disease
- •Rheumatoid arthritis
- •Have participated in a clinical trial within the last 30 days.
Arms & Interventions
IA Tranexamic acid + IV Tranexamic Acid
3 gram of Tranexamic acid diluted into 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.
Intervention: Tranexamic Acid
IA Saline Water + IV tranexamic Acid
30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.
Intervention: Saline water
IA Saline Water + IV tranexamic Acid
30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.
Intervention: Tranexamic Acid
Outcomes
Primary Outcomes
Total estimated blood loss
Time Frame: 24 hours surgery
Secondary Outcomes
- Thromboembolic complications(90 days postoperative)
- Total estimated blood loss(2 days after surgery)
- Blood transfusion(while hospitalized expected 3 days.)