Blood Loss, Postoperative Blood Loss, Thromboembolic Complications
Conditions
Keywords
Tranexamic Acid, Knee Arthroplasty, Blood loss, Blood transfusion, Thrombolic complication, Total blood loss 24 h after ended surgery., Total blood loss 2 days after ended surgery.
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.
Interventions
DRUGTranexamic Acid
An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.
DRUGSaline water
30 ml of Saline water injected into the knee capsula at the end of surgery.
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total estimated blood loss | 24 hours surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total estimated blood loss | 2 days after surgery | — |
| Thromboembolic complications | 90 days postoperative | 90 days followup for thromboembolic complications. |
| Blood transfusion | while hospitalized expected 3 days. | Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement |
Countries
Denmark
Outcome results
None listed