E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Blood loss in total hip replacement in patient with ostoearthritis and rheumatoid arthritis. |
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MedDRA Classification |
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 will reduce blood loss and subsequent blood transfusion significantly after total hip replacement when applied topically. |
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E.2.2 | Secondary objectives of the trial |
•The visible drain blood loss (First 48 hour). •Haemoglobin and Haematocrit drops (On day 2 postoperatively). •General quality of life measure (EUROQOL) •Oxford hip score •Length of stay. •Cost effectiveness analysis. •Complications |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Undergoing unilateral primary total hip replacement. |
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E.4 | Principal exclusion criteria |
1.Undergoing unilateral primary total hip replacement for tumour. 2.Allergic to Tranexamic acid. 3.Bleeding tendency (e.g. Haemophilic and platelets disorders). 4.Warfarin, treatment dose of LMWH or conventional heparin). 5.History of 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Blood transfusion rate and number of blood units transfused until discharge. Based on the recommendation of British Orthopaedic Association , Blood Transfusion Task Force, and The British Committee for Standards in Haematology , UK blood transfusion and tissue transplantation services, our transfusion protocol recommend the following: •Red cell transfusion is not indicated when Haemoglobin concentration is more than 10 g/dl. •Red cell transfusion is indicated when Haemoglobin concentration is < 7 g/dl and red cell transfusion should be given in relation to the rate of red cell loss. In otherwise stable patient, 2 units of red cell should be transfused, and then the clinical situation and Haemoglobin concentration should be reassessed. •The correct strategy for transfusing patients with haemoglobin between 7 and 10 is less clear. Clinicians often transfuse although the available evidence suggest this is not justified. BOA recommends that symptomatic patients should be transfused. Symptoms include fatigue, tiredness, short of breath, palpitation, chest pain, tachycardia and tachypnea. •In patients who tolerate anaemia poorly, example, patients over 65 years or those with cardiovascular diseases or respiratory diseases, consider adopting a higher threshold level for blood transfusion ( when Haemoglobin concentration is 8 g/dl).
The Haemoglobin level will be checked the next day after the transfusion and the same protocol is applied if the Haemoglobin level is low. profroma |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
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.8.5 | 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 | No |
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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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 | |