Randomised Controlled Trial of the Use of Topical Application of Tranexamic Acid in Primary Cemented Total Knee Replacement (TRANX-K). - TRANX-K
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10023227Term: Joint replacementIn 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.
- Registration Number
- EUCTR2007-007813-35-GB
- Lead Sponsor
- niversity Hospital of North Tees and Hartlepool
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method