Clinical trial • Phase III • Endocrinology
TRANEXAMIC ACID for Morbid obesity
Phase III trial of TRANEXAMIC ACID for Morbid obesity.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Morbid obesity
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 01-05-2024
- First CTIS Authorization Date
- 23-05-2024
Trial design
Randomised, sodium chloride (placebo) solution for infusion, intravenous use, max total dose 100 ml (comparator arm to tranexamic acid).-controlled Phase III trial across 6 sites in Netherlands.
- Randomised
- Yes
- Comparator
- SODIUM CHLORIDE (placebo) solution for infusion, intravenous use, max total dose 100 ml (comparator arm to TRANEXAMIC ACID).
- Target Sample Size
- 1524
Eligibility
Recruits 1524 No vulnerable populations selected. Patients unwilling to give informed consent are excluded; consent is required from adult participants (18+)..
- Vulnerable Population
- No vulnerable populations selected. Patients unwilling to give informed consent are excluded; consent is required from adult participants (18+).
Inclusion criteria
- {"criterion_text":"- Patients aged 18 years or older, eligible for bariatric surgery according to the IFSO guidelines and undergoing a laparoscopic (Roux-en-Y or one-anastomosis) gastric bypass."}
Exclusion criteria
- {"criterion_text":"- Patients unwilling to give informed consent, patients with a medical history of bleeding or venous thromboembolism and patients that use anticoagulants will be excluded."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Postoperative intervention due to haemorrhage (defined as: administration of packed red blood cells, surgical-, radiological-, or endoscopic intervention).","definition_or_measurement_approach":"Defined as administration of packed red blood cells, surgical, radiological, or endoscopic intervention."}
Secondary endpoints
- {"endpoint_text":"- Use hemostatic staple devices, amount of hemostatic staples, use of fibrin sealant, the amount of blood loss peroperatively, decrease in hemoglobin postoperatively, increase in heart rate postoperatively, hematemesis and/or melena, rates of postoperative hemorrhage (i.e. hemorrhage for which extra hemoglobin monitoring and/or administration of TXA and/or reinterventions), rates of VTE, other complications, hospitalization time, painscore, side effects of TXA, duration of primary surgery.","definition_or_measurement_approach":"Includes measures of hemostatic device use, peroperative blood loss volume, postoperative hemoglobin decrease, postoperative heart rate increase, hematemesis/melena, rates of postoperative hemorrhage requiring extra monitoring/TXA/reinterventions, rates of VTE, other complications, length of hospitalization, pain score, TXA side effects, and duration of primary surgery."}
Recruitment
- Planned Sample Size
- 1524
- Recruitment Window Months
- 31
- Consent Approach
- Informed consent required from participants; adults only (18+). Participants unwilling to give informed consent are excluded. Subject Information Sheet (SIS) and Informed Consent Form (ICF) for adults are provided.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 1524
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 66
- Number Of Sites
- 6
- Number Of Participants
- 1524
Sites
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Surgery
- Principal Investigator Name
- Eric Hazebroek
- Principal Investigator Email
- EHazebroek@Rijnstate.nl
- Contact Person Name
- Eric Hazebroek
- Contact Person Email
- EHazebroek@Rijnstate.nl
- Site Name
- Elisabeth-Tweesteden Ziekenhuis
- Department Name
- Surgery
- Principal Investigator Name
- Barbara Langenhoff
- Principal Investigator Email
- b.langenhoff@etz.nl
- Contact Person Name
- Barbara Langenhoff
- Contact Person Email
- b.langenhoff@etz.nl
- Site Name
- Stichting OLVG
- Department Name
- Surgery
- Principal Investigator Name
- Ruben van Veen
- Principal Investigator Email
- r.n.vanveen@olvg.nl
- Contact Person Name
- Ruben van Veen
- Contact Person Email
- r.n.vanveen@olvg.nl
- Site Name
- Ziekenhuisgroep Twente Stichting
- Department Name
- Surgery
- Principal Investigator Name
- Marc van Det
- Principal Investigator Email
- obesitas@zgt.nl
- Contact Person Name
- Marc van Det
- Contact Person Email
- obesitas@zgt.nl
- Site Name
- Sint Franciscus Vlietland Groep Stichting
- Department Name
- Surgery
- Principal Investigator Name
- Jan Apers
- Principal Investigator Email
- J.apers@Franciscus.nl
- Contact Person Name
- Jan Apers
- Contact Person Email
- J.apers@Franciscus.nl
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- Surgery
- Principal Investigator Name
- Evert-Jan Boerma
- Principal Investigator Email
- e.boerma@zuyderland.nl
- Contact Person Name
- Evert-Jan Boerma
- Contact Person Email
- e.boerma@zuyderland.nl
Sponsor
Primary sponsor
- Full Name
- Sint Franciscus Vlietland Groep Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- TRANEXAMIC ACID
- Active Substance
- TRANEXAMIC ACID
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Maximum Dose
- 1500 mg
- Investigational Product Name
- SODIUM CHLORIDE
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Maximum Dose
- 100 ml
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