The benefit of additional Tranexamic Acid (TXA) injected intra-articular at the end of surgery for patients undergoing a unilateral total knee arthroplasty in addition to conventional IV TXA to reduce the bleeding. MedDRA version: 14.1 Level: LLT Classification code 10003398 Term: Arthroplasty of knee System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Tranexamsyre
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tranexamic acid
Other descriptive name: TRANEXAMIC ACID
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
Anders Troelsen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: =18 years. Undergoing surgery for unilateral total knee prothesis. Give one's consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • Allergic to TXA. • In treatment with the following antikoagulantia: ADP receptorinhibitors, Vitamin K antagonist (within 5 to 7 days before the operation.). Faktor Xa inhibitors, trombine-inhibitors. • Use og oral antikonceptiva • Known with Trombofili. • Reduced kidney function (S-kreatinine > 120 micromol/L) • Participated in a clinical trial within the last 30 days. • Alcoholisme and morphinism. • Females: Menstruation within the last 12 months. • Patients who are not able to speak and under stand Danish. • Patients who refuse to receive blood products. • Present acute thromboembolic event (DVT, AMI, lung embolia, cerebral infarction, pulmonary embolism) •Disseminated intravascular coagulation (DIC) or active thromoembolic disease. • Present active cancer disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this RCT-study we investigate the potential additive effect of intra-articular injected Tranexamic Acid (TXA) for the total blood loss in unilateral knee arthroplasty in addition to conventional treatment with IV TXA. The intervention group will be given IV TXA at the start of surgery + injection of TXA into the joint (end surgery) VS. TXA TXA at the start of surgery + injection af equal volume of NaCl (placebo). Primary endpoint is total blood loss 24 hours after surgery. ;Secondary Objective: Secondary endpoints is total bleeding 2 days after surgery, likewise the amount of blood transfusion and the thromboembolic events within the first 90 days of surgery. ;Primary end point(s): Total blood loss 24 h after the operation.;Timepoint(s) of evaluation of this end point: 24 hours after the operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Total blood loss on the morning af the 2nd postoperative day.;Timepoint(s) of evaluation of this end point: 2nd postoperative day | — |
Countries
Denmark
Contacts
Public ContactChristian Skovgaard Nielsen
Clinical Orthopaedic Research Hvidovre
Outcome results
None listed