E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The benefit of additional Tranexamic Acid (TXA) injected intra-articular at the end of surgery for patients undergoing a unilateral total knee arthroplasty in addition to conventional IV TXA to reduce the bleeding. |
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E.1.1.1 | Medical condition in easily understood language |
Tranevamic Acid is a drug which decreases the bleeding at the site of a wound be stabilizing the blood clot. |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003398 |
E.1.2 | Term | Arthroplasty of knee |
E.1.2 | System Organ Class | 100000004865 |
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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 |
In this RCT-study we investigate the potential additive effect of intra-articular injected Tranexamic Acid (TXA) for the total blood loss in unilateral knee arthroplasty in addition to conventional treatment with IV TXA. The intervention group will be given IV TXA at the start of surgery + injection of TXA into the joint (end surgery) VS. TXA TXA at the start of surgery + injection af equal volume of NaCl (placebo). Primary endpoint is total blood loss 24 hours after surgery. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints is total bleeding 2 days after surgery, likewise the amount of blood transfusion and the thromboembolic events within the first 90 days of surgery. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
≥18 years.
Undergoing surgery for unilateral total knee prothesis.
Give one's consent. |
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E.4 | Principal exclusion criteria |
• Allergic to TXA. • In treatment with the following antikoagulantia: ADP receptorinhibitors, Vitamin K antagonist (within 5 to 7 days before the operation.). Faktor Xa inhibitors, trombine-inhibitors. • Use og oral antikonceptiva • Known with Trombofili. • Reduced kidney function (S-kreatinine > 120 micromol/L) • Participated in a clinical trial within the last 30 days. • Alcoholisme and morphinism. • Females: Menstruation within the last 12 months. • Patients who are not able to speak and under stand Danish. • Patients who refuse to receive blood products. • Present acute thromboembolic event (DVT, AMI, lung embolia, cerebral infarction, pulmonary embolism) •Disseminated intravascular coagulation (DIC) or active thromoembolic disease. • Present active cancer disease. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total blood loss 24 h after the operation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 hours after the operation. |
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E.5.2 | Secondary end point(s) |
Total blood loss on the morning af the 2nd postoperative day. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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.8.2.4 | 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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60 patients who have completed at least the primary outcome |
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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 | |