E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language | |
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10059610 | E.1.2 | Term | Obesity surgery | E.1.2 | System Organ Class | 100000004865 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10027966 | E.1.2 | Term | Morbid obesity | E.1.2 | System Organ Class | 100000004861 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10068900 | E.1.2 | Term | Bariatric surgery | E.1.2 | System Organ Class | 100000004865 | |
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 | This trial aims to investigate if peroperative administration of TXA can reduce the peroperative and postoperative hemorrhage rates in laparoscopic gastric bypass. | |
E.2.2 | Secondary objectives of the trial | Secondary outcome measures are the use of haemostatic staple devices and fibrin sealant preoperatively, postoperatively decrease in haemoglobin, increase in heart rate, rates of suspicions of postoperative haemorrhage (i.e. haemorrhage for which extra haemoglobin monitoring and administration of TXA) and rates of VTE, other complications, hospitalization time. | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | In order to be eligible to participate in this study, a subject must meet all of the following criteria: Primary bariatric procedure; good command of the Dutch or English language. | |
E.4 | Principal exclusion criteria | A potential subject who meets any of the following criteria will be excluded from participation in this study: Patients unwilling to give informed consent, patients with a medical history of bleeding or VTE and patients who use therapeutic anticoagulants. Patients will also be excluded in case of peroperative arterial bleeding or (iatrogenic) bleeding coming from surrounding organs or vascular structures such as the liver or the spleen. | |
E.5 End points |
E.5.1 | Primary end point(s) | Primary outcome measures is the reintervention rates of postoperative hemorrhage | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | Reintervention (administration of packed red blood cells or, surgical-, radiological-, or endoscopic intervention) evaluated within 30 days postoperatively. | |
E.5.2 | Secondary end point(s) | Secondary outcome measures are the use of haemostatic staple devices and fibrin sealant preoperatively. Decrease in haemoglobin and increase in heart rate one day postoperatively. Rates of suspicions of postoperative haemorrhage (i.e. haemorrhage for which extra haemoglobin monitoring and administration of TXA) and rates of VTE, other complications within 30 days postoperatively and hospitalization time in hours. | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | Within 3 months after surgery | |
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 | No |
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 | 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 | 7 |
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 | 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 | 3 months after surgery of the last subject undergoing the trial | |
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 | |