E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
All adults (+ 18 yrs) who were scheduled for a primary unilateral total hip arthroplasty due to osteoarthritis. |
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E.1.1.1 | Medical condition in easily understood language |
All adults (+ 18 yrs) who were scheduled for a primary unilateral total hip arthroplasty (placement of total hip prothesis due to osteoarthritis. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 |
In this study, we will compare the efficacy of intra-articular application of TXA to the intravenous administration in terms of postoperative blood loss. Our hypothesis is that there is no significant difference in postoperative blood loss between intra-articular and intravenous administration of TXA.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All adults (patients over the age of eighteen years) who were scheduled for a primary unilateral total hip arthroplasty due to osteoarthritis at Ziekenhuis Oost-Limburg, Genk, Belgium are eligible for inclusion in the study. |
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E.4 | Principal exclusion criteria |
A patient is excluded from the study if he or she has a history of coagulopathy, allergy to tranexamic acid, preoperative anemia, fibrinolytic disorders, history of arterial or venous thromboembolic disease, disturbances of color vision, pregnancy, breastfeeding, major comorbidities and participation in another clinical trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is the postoperative blood loss. The difference between total blood loss and intraoperative blood loss is used to predict the postoperative blood loss for each patient. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Measured with a simple blood sample on day one after surgery |
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E.5.2 | Secondary end point(s) |
The secondary outcomes includes: 1) The rate of perioperative and postoperative blood transfusions 2) The number of blood units transfused 3) The length of hospital stay 4) The severity of pain at rest as determined with use of a visual analog scale (possible range 0 to 10). 5) Perioperative given intravenous isotonic fluid
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1)Patients will be followed for the duration of hospital stay, an expected average of 5 days 2)Patients will be followed for the duration of hospital stay, an expected average of 5 days 3)3) The length of hospital stay 4)Patients will be followed for the duration of hospital stay, an expected average of 5 days (0-10 scale) 5)Patients will be followed for the duration of hospital stay, an expected average of 5 days |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Also tranexamic acid but other application (intravenous instead of intraarticular) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |