E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023227 |
E.1.2 | Term | Joint replacement |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To find out whether Tranexamic acid can reduce blood loss significantly after total knee replacement when applied topically.
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E.2.2 | Secondary objectives of the trial |
•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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Undergoing unilateral primary cemented total knee replacement. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Data monitoring committee consists of Professor James Mason and Professor Hungin from School of Health, University of Durham. Data will be reviewed when 75 patients have recruited to assess safety profile or earlier if safety concern rises. The trial will be stopped if there is an excess of DVT and fatal pulmonary embolism in the Tranexamic acid group in comparison to the placebo group of 12 to 3 and 6 to 1 respectively (corrected chi-square and Fisher's exact tests; Alpha 0.1 and power 80%). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |