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New treatment option for Surgical Blood Loss
Official title Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery
ClinicalTrials.gov ID: NCT06414031
What this study is testing
What is Tranexamic Acid?
Tranexamic Acid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for surgical blood loss.
Also referred to as Tranexamsäure Carinopharm 100mg/ml.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. .
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or above
- 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 commencing study treatment. Females of reproductive potential must...
You likely can't join if
- Severe anaemia, defined as a haemoglobin concentration \<8 g/dL (\<5 mmol/L) or anaemia with haemoglobin concentration ≥8 to \<10 g/dL (≥5,0 to \<6,2...
- Clinical signs of tachycardia, e.g., resting heart rate \>100 beats/minute, palpitation 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 treatment (e.g., factor deficiency with the need of perioperative...
See the full eligibility criteria
- Age 18 years or above
- 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 commencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the...
- Severe anaemia, defined as a haemoglobin concentration \<8 g/dL (\<5 mmol/L) or anaemia with haemoglobin concentration ≥8 to \<10 g/dL (≥5,0 to \<6,2 mmol/l) and one or several of the following symptoms suggesting...
- Clinical signs of tachycardia, e.g., resting heart rate \>100 beats/minute, palpitation 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 treatment (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 tranexamic acid
- Recent (\<30 days) thromboembolic event
- History of medically confirmed convulsions
- In female people: pregnancy or lactation
The study team makes the final eligibility decision.
Where it's taking place
- Dresden, Saxony, Germany
- Halle, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dresden, Saxony, Germany; Halle, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.