Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
850
Countries
1
Sites
12
bleeding and transfusion requirements for major abdominal surgery, i.e., esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, and hepatectomy
The primary objective of this trial is to assess whether intraoperative administration of Tranexamic Acid reduces hemorrhage and thus the need for intra- and postoperative transfusion of packed red blood cells for major abdominal operations.
Key facts
- Sponsor
- Martin-Luther-Universitaet Halle-Wittenberg
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 17 Jun 2024 → ongoing
- Decision date (initial)
- 2024-04-25
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Federal Ministry of Education and Research of Germany
External identifiers
- EU CT number
- 2023-509970-43-01
- ClinicalTrials.gov
- NCT06414031
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Prophylaxis
The primary objective of this trial is to assess whether intraoperative administration of Tranexamic Acid reduces hemorrhage and thus the need for intra- and postoperative transfusion of packed red blood cells for major abdominal operations.
Secondary objectives 1
- Secondary objectives are to evaluate the amount of intraoperative blood loss, the safety of administering tranexamic acid, the occurrence of complications after the operation, the length of inpatient hospital stay, and quality of life.
Conditions and MedDRA coding
bleeding and transfusion requirements for major abdominal surgery, i.e., esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, and hepatectomy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10051536 | Intraoperative bleeding | 10022117 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Recruitment Period Study Recruitment at 11 centers in Germany
|
Randomised Controlled | Double | [{"id":124239,"code":2,"name":"Investigator"},{"id":124237,"code":3,"name":"Monitor"},{"id":124238,"code":5,"name":"Carer"},{"id":124236,"code":1,"name":"Subject"}] | Tranexamic Acid 2000mg/20ml: The first dose of 1000mg Tranexamic Acid ad 50 ml is applied intravenously via a central or peripheral line after anaesthesia induction and approximately 10 minutes prior to skin incision as a bolus (infusion rate 300 mL/hour). The second dose of 1000mg Tranexamic Acid ad 50 ml is administered intravenously via a central or peripheral line as a continuous infusion (infusion rate 6.25 mL / hour) until complete skin closure or eight hours have passed from skin incision, whatever happens first. Placebo NaCl 0,9% 20ml: The first dose ad 50 ml NaCl 0,9% is applied intravenously via a central or peripheral line after anaesthesia induction and approximately 10 minutes prior to skin incision as a bolus (infusion rate 300 mL/hour). The second dose ad 50 ml NaCl 0,9% is administered intravenously via a central or peripheral line as a continuous infusion (infusion rate 6.25 mL / hour) until complete skin closure or eight hours have passed from skin incision, whatever happens first. |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- In accordance with data protection regulations, individual de-identified individual participant data will be shared with other researchers upon reasonable and justified request. It is planned to store de-identified individual participant data on the B2SHARE repository of the EUDAT collaborative data infrastructure. IPD will be made available after analysis of the primary outcome and after publication of pertaining results.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509970-43-00 | Tranexamic Acid for reduction of intra- and postoperative TRansfusion Requirements in elective Abdominal surgery: randomized controlled trial (TATRA) | Martin-Luther-Universitaet Halle-Wittenberg |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patients ≥18 years
- Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy
- Adequate renal function with serum creatinine <250 μmol/L (2.82 mg/dL)
- Written informed consent obtained before randomization
- Negative pregnancy test for women of childbearing potential within 14 days of com-mencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of <1% per year; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).
- Capability to understand character and individual consequences of trial participation
Exclusion criteria 9
- Severe anaemia (haemoglobin concentration <8 g/dL (<5 mmol/L)) or Anaemia with haemoglobin concentration ≥8 to <10 g/dL (≥5,0 100 beats/minute, palpi-tation etc. • Clinical signs of hypotension, e.g., resting systolic blood pressure <100 mmHg, orthostatic dysregulation etc. • Clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate >20 breaths/min.
- Thrombocytopenia with platelets <60 x 109 /L
- Confirmed bleeding disorder with the need for specific preventive perioperative treat-ment (e.g., factor deficiency with the need of perioperative substitution)
- A priori refusal of blood transfusions
- Confirmed thrombophilia with a pertinent need for perioperative anticoagulation
- Allergy / hypersensitivity to TXA
- Recent (<30 days) thromboembolic event
- History of medically confirmed convulsions
- In female subjects: pregnancy or lactation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Intra- or postoperative transfusion of at least one unit of Packed Red Blood Cells (PRBCs)
Secondary endpoints 1
- - Number of transfused Packed Red Blood Cells per patient - Estimated amount of intraoperative blood loss - Time to transfusion - Number and severity of postoperative in-hospital complications/mortality (max. 30 days) - Duration of hospital stay - Operation / Anaesthesia duration - D-dimer levels - Quality of life
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Tranexamsäure Carinopharm 100mg/ml Injektions-/Infusionslösung
PRD3732799 · Product
- Active substance
- Tranexamic Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS PERFUSION USE
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA02 — TRANEXAMIC ACID
- Marketing authorisation
- 88847.00.00
- MA holder
- CARINOPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Refilling by pharmacy with manufacturing permission
Placebo 1
Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung
PRD564001 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS PERFUSION USE
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 6726174.00.00
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Refilling by pharmacy with manufacturing permission
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Martin-Luther-Universitaet Halle-Wittenberg
- Sponsor organisation
- Martin-Luther-Universitaet Halle-Wittenberg
- Address
- Ernst-Grube-Strasse 40, Kroellwitz Kroellwitz
- City
- Halle (Saale)
- Postcode
- 06120
- Country
- Germany
Scientific contact point
- Organisation
- Martin-Luther-Universitaet Halle-Wittenberg
- Contact name
- Ronellenfitsch
Public contact point
- Organisation
- Martin-Luther-Universitaet Halle-Wittenberg
- Contact name
- Ronellenfitsch
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 850 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Technische Universitaet Dresden
Department of Gastrointestinal, Thoracic and Vascular Surgery, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum Nuernberg
Department of General, Visceral and Thoracic Surgery, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Universitaetsklinikum Aachen AöR
Department of General, Visceral, and Transplantation Surgery, Pauwelsstrasse 30, 52074, Aachen
Martin-Luther-Universitaet Halle-Wittenberg
Department of Visceral, Vascular, and Endocrine Surgery, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Chirurgie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Heidelberg AöR
Klinisches Studienzentrum Chirurgie, Im Neuenheimer Feld 420, 69120, Heidelberg
Klinikum der Universitaet Muenchen AöR
Department of General, Visceral and Transplant Surgery, Marchioninistrasse 15, Hadern, Munich
Carl Von Ossietzky Universitaet Oldenburg
Department of General, Visceral, and Transplantation Surgery, Ammerlaender Heerstrasse 114-118, Wechloy, Oldenburg
Universitaetsklinikum Mannheim GmbH
Klinik und Poliklinik für Chirurgie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Klinikum Lippe GmbH
Universitätsklinik für Allgemein- und Visceralchirurgie, Roentgenstrasse 18, Innenstadt, Detmold
Goethe University Frankfurt
Klinik für Allgemein- Viszeral- Transplantations- und Thoraxchirurgie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Ulm AöR
Klinik für Allgemein- und Viszeralchirurgie, Albert-Einstein-Allee 29, Eselsberg, Ulm
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 |
|---|---|---|---|---|---|
| Germany | 2024-06-17 | 2024-06-17 |
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_DE_TATRA_2023-509970-43-01__clear | 2.3 |
| Protocol (for publication) | D1_Protocol_EN_TATRA_2023-509970-43-01 | 2.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TATRA_2023-509970-43 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_TATRA_2023-509970-43-01_ | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_TATRA_2023-509970-43-01__ | 2.3 |
| Subject information and informed consent form (for publication) | L2_QL Questionnaire_SF12_DE_2023-509970-43-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_DE_Tranexamsaure Carinopharm | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_TATRA_DE_2023_509970_43 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-14 | Germany | Acceptable 2024-04-15
|
2024-04-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-05 | Germany | Acceptable 2024-08-06
|
2024-08-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-21 | Germany | Acceptable 2024-10-11
|
2024-10-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-14 | Germany | Acceptable 2025-04-11
|
2025-05-02 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-20 | Germany | Acceptable 2025-04-11
|
2025-05-20 |