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Topical TRANeXamic acid in total Knee replacement

Topical (intra-articular) TRANeXamic acid reduces blood loss and transfusion rates following total Knee replacement: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68578366
Enrollment
150
Registered
2012-04-30
Start date
2008-08-15
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

The operation will be performed in the standard manner. Normally, there is no chemical intervention to reduce blood loss. In our study, at the end of the operation and before closing the wound, the st

Sponsors

University Hospital of North Tees and Hartlepool (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Undergoing unilateral primary cemented total knee replacement

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 platelets disorders) 4. Warfarin, treatment dose of low molecular weight heparin (LMWH) or conventional heparin 5. History of deep vein thrombosis (DVT) and pulmonary embolism 6. Renal failure with creatinine > 250 micromole/l 7. Female subjects of child bearing potential must have a negative pregnancy test

Design outcomes

Primary

MeasureTime frame
Blood transfusion required (number of patients needed blood transfusion and number of units of blood transfused until patient is discharged)

Secondary

MeasureTime frame
1. The visible 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. 2. Blood loss in recovery room (visible drain blood loss just before patient leaves the recovery room) 3. Haemoglobin and haematocrit drops (on day 2 postoperatively) 4. General quality of life measure (EUROQOL) preoperative and at 3 months postoperative. This will be completed as per EuroQol group recommendation in their user guide version 1.0 November 2007.?20] 5. Oxford knee score preoperative and at 3 months postoperative. This will be completed as per authors? recommendation in their paper ?The use of the Oxford hip and knee scores? published in the Journal of Bone and Joint Surgery 2007 . Each of the 12 questions is scored from 4 to 0, with 4 representing the best outcome/least symptoms. The scores from each question were added so that the overall figure lies between 48 and 0, with 48 being the best possible outcome.There are several studies confirmed the validity, consistency and sensitivity of the above two outcome measures. 6. Length of stay 7. Cost effectiveness analysis 8. Cost analysis reflecting changes in resources utilisation (length of stay, blood transfusion, and complications treatment costs) 9. Complications

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026