Clinical trial • Not applicable • Other
Tranexamic acid for Intraoperative bleeding | Transfusion requirements in major abdominal surgery
Not applicable trial of Tranexamic acid for Intraoperative bleeding | Transfusion requirements in major abdominal surgery.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Intraoperative bleeding | Transfusion requirements in major abdominal surgery
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-02-2024
- First CTIS Authorization Date
- 25-04-2024
Trial design
Randomised, 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."-controlled Not applicable trial across 11 sites in Germany.
- Randomised
- Yes
- Comparator
- 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."
- Target Sample Size
- 850
- Trial Duration For Participant
- 30
Stratification factors
- Planned surgical access (open vs. minimally-invasive)
- Planned operation (esophagectomy | gastrectomy | colectomy | rectal resection | pancreatic resection | hepatectomy)
Eligibility
Recruits 850 Vulnerable population selected. Participants must be capable to understand the nature and individual consequences of trial participation and must provide written informed consent prior to randomization (criterion: "Capability to understand character and individual consequences of trial participation"; "Written informed consent obtained before randomization"). Subject information and informed consent forms are provided (documents L1 / L2 exist). No procedures for assent or minor consent are described..
- Pregnancy Exclusion
- In female subjects: pregnancy or lactation.
- Vulnerable Population
- Vulnerable population selected. Participants must be capable to understand the nature and individual consequences of trial participation and must provide written informed consent prior to randomization (criterion: "Capability to understand character and individual consequences of trial participation"; "Written informed consent obtained before randomization"). Subject information and informed consent forms are provided (documents L1 / L2 exist). No procedures for assent or minor consent are described.
Inclusion criteria
- {"criterion_text":"- Patients ≥18 years"}
- {"criterion_text":"- Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy"}
- {"criterion_text":"- Adequate renal function with serum creatinine <250 μmol/L (2.82 mg/dL)"}
- {"criterion_text":"- Written informed consent obtained before randomization"}
- {"criterion_text":"- 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)."}
- {"criterion_text":"- Capability to understand character and individual consequences of trial participation"}
Exclusion criteria
- {"criterion_text":"- 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."}
- {"criterion_text":"- Thrombocytopenia with platelets <60 x 109 /L"}
- {"criterion_text":"- Confirmed bleeding disorder with the need for specific preventive perioperative treat-ment (e.g., factor deficiency with the need of perioperative substitution)"}
- {"criterion_text":"- A priori refusal of blood transfusions"}
- {"criterion_text":"- Confirmed thrombophilia with a pertinent need for perioperative anticoagulation"}
- {"criterion_text":"- Allergy / hypersensitivity to TXA"}
- {"criterion_text":"- Recent (<30 days) thromboembolic event"}
- {"criterion_text":"- History of medically confirmed convulsions"}
- {"criterion_text":"- In female subjects: pregnancy or lactation."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Intra- or postoperative transfusion of at least one unit of Packed Red Blood Cells (PRBCs)","definition_or_measurement_approach":"Occurrence of intra- or postoperative transfusion of at least one unit of Packed Red Blood Cells (PRBCs); primary objective assesses reduction in need for intra- and postoperative PRBC transfusion after intraoperative administration of tranexamic acid."}
Secondary endpoints
- {"endpoint_text":"- Number of transfused Packed Red Blood Cells per patient","definition_or_measurement_approach":"Count of units of PRBCs transfused per patient."}
- {"endpoint_text":"- Estimated amount of intraoperative blood loss","definition_or_measurement_approach":"Estimated intraoperative blood loss measured during surgery."}
- {"endpoint_text":"- Time to transfusion","definition_or_measurement_approach":"Time from surgery start to initiation of transfusion."}
- {"endpoint_text":"- Number and severity of postoperative in-hospital complications/mortality (max. 30 days)","definition_or_measurement_approach":"Recording and grading of postoperative in-hospital complications and mortality up to a maximum of 30 days postoperatively."}
- {"endpoint_text":"- Duration of hospital stay","definition_or_measurement_approach":"Length of inpatient hospital stay in days."}
- {"endpoint_text":"- Operation / Anaesthesia duration","definition_or_measurement_approach":"Recorded duration of the surgical operation and anesthesia."}
- {"endpoint_text":"- D-dimer levels","definition_or_measurement_approach":"Measurement of D-dimer laboratory levels."}
- {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Assessment of patient quality of life (questionnaire; QL Questionnaire SF12 referenced)."}
Recruitment
- Planned Sample Size
- 850
- Recruitment Window Months
- 18
- Consent Approach
- Written informed consent is obtained from each participant before randomization; participants must be capable of understanding the nature and individual consequences of participation. Subject information and informed consent forms (documents L1/L2) are available (German-language forms are present; protocol also available in English).
Methods
- Site-based recruitment at participating hospitals: study recruitment at 11 centers in Germany (recruitment at the listed participating hospitals/clinics).
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 850
Germany
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 02-05-2025
- Processing Time Days
- 382
- Number Of Sites
- 11
- Number Of Participants
- 850
Sites
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Klinik und Poliklinik für Chirurgie
- Principal Investigator Name
- Christoph Reißfelder
- Principal Investigator Email
- christoph.reissfelder@umm.de
- Contact Person Name
- Christoph Reißfelder
- Contact Person Email
- christoph.reissfelder@umm.de
- Site Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Department Name
- Department of Visceral, Vascular, and Endocrine Surgery
- Principal Investigator Name
- Ulrich Ronellenfitsch
- Principal Investigator Email
- ulrich.ronellenfitsch@uk-halle.de
- Contact Person Name
- Ulrich Ronellenfitsch
- Contact Person Email
- ulrich.ronellenfitsch@uk-halle.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Department of Gastrointestinal, Thoracic and Vascular Surgery
- Principal Investigator Name
- Olga Radulova-Mauersberger
- Principal Investigator Email
- olga.radulova-mauersberger@uniklinikum
- Contact Person Name
- Olga Radulova-Mauersberger
- Contact Person Email
- olga.radulova-mauersberger@uniklinikum
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Allgemein- und Viszeralchirurgie
- Principal Investigator Name
- Patrick Téoule
- Principal Investigator Email
- patrick.teoule@uniklinik-ulm.de
- Contact Person Name
- Patrick Téoule
- Contact Person Email
- patrick.teoule@uniklinik-ulm.de
- Site Name
- Klinikum Lippe GmbH
- Department Name
- Universitätsklinik für Allgemein- und Visceralchirurgie
- Principal Investigator Name
- Jens Höppner
- Principal Investigator Email
- jens.hoeppner@klinikum-lippe.de
- Contact Person Name
- Jens Höppner
- Contact Person Email
- jens.hoeppner@klinikum-lippe.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Klinik und Poliklinik für Chirurgie
- Principal Investigator Name
- Daniel Reim
- Principal Investigator Email
- daniel.reim@tum.de
- Contact Person Name
- Daniel Reim
- Contact Person Email
- daniel.reim@tum.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Department of General, Visceral and Transplant Surgery
- Principal Investigator Name
- Elnaz Payani
- Principal Investigator Email
- elnaz.payani@med.uni-muenchen.de
- Contact Person Name
- Elnaz Payani
- Contact Person Email
- elnaz.payani@med.uni-muenchen.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Klinik für Allgemein- Viszeral- Transplantations- und Thoraxchirurgie
- Principal Investigator Name
- Armin Wiegering
- Principal Investigator Email
- armin.wiegering@unimedizin-ffm.de
- Contact Person Name
- Armin Wiegering
- Contact Person Email
- armin.wiegering@unimedizin-ffm.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Klinisches Studienzentrum Chirurgie
- Principal Investigator Name
- Frank Pianka
- Principal Investigator Email
- frank.pianka@med.uni-heidelberg.de
- Contact Person Name
- Frank Pianka
- Contact Person Email
- frank.pianka@med.uni-heidelberg.de
- Site Name
- Klinikum Nuernberg
- Department Name
- Department of General, Visceral and Thoracic Surgery
- Principal Investigator Name
- Patrick Heger
- Principal Investigator Email
- patrick.heger@klinikum-nuernberg.de
- Contact Person Name
- Patrick Heger
- Contact Person Email
- patrick.heger@klinikum-nuernberg.de
- Site Name
- Carl Von Ossietzky Universitaet Oldenburg
- Department Name
- Department of General, Visceral, and Transplantation Surgery
- Principal Investigator Name
- Simon Schäfer
- Principal Investigator Email
- Studienkoordination-ACH-Innere@klinikum-oldenburg.de
- Contact Person Name
- Simon Schäfer
- Contact Person Email
- Studienkoordination-ACH-Innere@klinikum-oldenburg.de
Sponsor
Primary sponsor
- Full Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Third parties
- {"country":"Germany","full_name":"Federal Ministry of Education and Research of Germany","duties_or_roles":"Monetary support / funding","organisation_type":""}
Investigational products
- Investigational Product Name
- Tranexamsäure Carinopharm 100mg/ml Injektions-/Infusionslösung
- Active Substance
- Tranexamic acid
- Modality
- Small molecule
- Routes Of Administration
- Intravenous perfusion
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation present; mrpNumber DE/H/3730/001)
- Starting Dose
- 1000 mg IV (in 50 ml) as bolus after anaesthesia induction ~10 minutes prior to skin incision
- Dose Levels
- 1000 mg IV bolus then 1000 mg IV continuous infusion (both in 50 ml each) until skin closure or up to 8 hours from skin incision
- Frequency
- Two administrations: initial bolus then continuous infusion until skin closure or 8 hours
- Maximum Dose
- 2000 mg (total)
- Investigational Product Name
- Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung
- Active Substance
- Sodium chloride (0.9%)
- Modality
- Small molecule
- Routes Of Administration
- Intravenous perfusion
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 50 ml IV bolus after anaesthesia induction ~10 minutes prior to skin incision
- Dose Levels
- 50 ml IV bolus then 50 ml IV continuous infusion at 6.25 mL/hour until skin closure or up to 8 hours from skin incision
- Frequency
- Two administrations: initial bolus then continuous infusion until skin closure or 8 hours
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