In this study Tranexamic acid efficacy in reducing blood loss will be investigated in total knee replacement.Tranexamic acid will be applied topically to the exposed tissue around the knee joint prior to the wound closure and tourniquet release. It is anticipated that this method of administration will be quicker, easier and have less systemic side effect. MedDRA version: 9.1 Level: LLT Classification code 10023227 Term: Joint replacement
Conditions
Interventions
Trade Name: Cyklokapron
Product Name: Cyklokapron
Product Code: NA
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Loca
Sponsors
University Hospital of North Tees and Hartlepool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Undergoing unilateral primary cemented total knee replacement. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Undergoing unilateral primary total knee replacement for trauma or tumour. 2.Allergic to Tranexamic acid. 3.Bleeding tendency (e.g. Haemophilic and ITP). 4.Warfarin, treatment dose of LMWH or conventional heparin). 5.History of DVT and pulmonary embolism. 6.Female subjects of child bearing potential must have a negative pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find out whether Tranexamic acid can reduce blood loss significantly after total knee replacement when applied topically. ;Secondary Objective: •Blood loss in recovery room. •Blood transfusion required and volume of blood transfused (until discharge).* •Haemoglobin and Haematocrit drops ( On day 2 postoperatively) •General quality of life measure (EUROQOL) preoperative and at 3 months postoperative. •Oxford knee score preoperative and at 3 months postoperative. •Length of stay. •Complications: 1. Wound infection. (Clinical and / or microbiological diagnosis). 2. Deep venous thrombosis (confirmed radiologically). 3. Pulmonary embolism (confirmed radiologically). 4. Myocardial infarction. (Confirmed by ECG or cardiac enzymes). 5. Cerebrovascular accident.(Confirmed by CT scan). 6. Death until discharge. •Cost effectiveness analysis. Cost analysis reflecting changes in resources utilisation (length of stay, blood transfusion, and complications treatment costs). ;Primary end point(s): •Drain blood loss (First 48 hour). Total knee replacement is performed in bloodless field. The blood is exsangunated from the limb and tourniquet applied higher up to keep the limb bloodless. After suturing the skin and applying the pressure dressing, the tourniquet is released allowing the blood to flow into the limb. Any bleeding will be sucked out by the vacuum drain. Hence drain blood loss is good reflection of total blood loss after total knee replacement. The outcome is a continuous variable, measured in millilitre (ml) and will be analysed by two sample t-tests. Fifty percent reduction in mean drain blood loss will be considered significant. | — |
Countries
United Kingdom
Outcome results
None listed