Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,524
Countries
1
Sites
6
Morbid obesity
This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo gastric bypass surgery.
Key facts
- Sponsor
- Sint Franciscus Vlietland Groep Stichting
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 28 Apr 2023 → ongoing
- Decision date (initial)
- 2024-05-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513570-22-00
- EudraCT number
- 2022-001384-27
- ClinicalTrials.gov
- NCT05464394
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo gastric bypass surgery.
Conditions and MedDRA coding
Morbid obesity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10068900 | Bariatric surgery | 10042613 |
| 21.0 | LLT | 10027966 | Morbid obesity | 10027433 |
| 21.1 | LLT | 10059610 | Obesity surgery | 10042613 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513218-36-00 | Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage (PATRY study): a randomized controlled trial | Sint Franciscus Vlietland Groep Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 1
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- Postoperative intervention due to haemorrhage (defined as: administration of packed red blood cells, surgical-, radiological-, or endoscopic intervention).
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB11214MIG · Substance
- Active substance
- Tranexamic Acid
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sint Franciscus Vlietland Groep Stichting
- Sponsor organisation
- Sint Franciscus Vlietland Groep Stichting
- Address
- Kleiweg 500
- City
- Rotterdam
- Postcode
- 3045 PM
- Country
- Netherlands
Scientific contact point
- Organisation
- Sint Franciscus Vlietland Groep Stichting
- Contact name
- Mabel Kwakkelstein
Public contact point
- Organisation
- Sint Franciscus Vlietland Groep Stichting
- Contact name
- Mabel Kwakkelstein
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 1,524 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Elisabeth-Tweesteden Ziekenhuis
Surgery, Dr. Deelenlaan 5, 5042 AD, Tilburg
Rijnstate Ziekenhuis Stichting
Surgery, Wagnerlaan 55, 6815 AD, Arnhem
Ziekenhuisgroep Twente Stichting
Surgery, Zilvermeeuw 1, 7609 PP, Almelo
Stichting OLVG
Surgery, Jan Tooropstraat 164, 1061 AE, Amsterdam
Zuyderland Medisch Centrum Stichting
Surgery, Henri Dunantstraat 5, 6419 PC, Heerlen
Sint Franciscus Vlietland Groep Stichting
Surgery, Kleiweg 500, 3045 PM, Rotterdam
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2023-04-28 | 2024-05-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513570-22-00_TC | 4 |
| Protocol (for publication) | D1_protocol PATRY 2024-513570-22-00 | 4 |
| Protocol (for publication) | D1_SoC Protocol | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_TC | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC tranexaminezuur | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-513570-22-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-01 | Netherlands | Acceptable 2024-05-23
|
2024-05-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-21 | Netherlands | Acceptable 2024-07-22
|
2024-07-22 |