Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUlrich Ronellenfitsch, MD
About this trial
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. . It will also inform about safety of tranexamic acid in this setting.
The main question it aims to answer is: Does tranexamic acid lower the probability of receiving at least one blood transfusion during or after surgery?
Participants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic Acid
DrugIntravenous administration
Placebo
DrugIntravenous administration
Treatment groups
850 Participants
are divided into 2 treatment groupsGroup A: Tranexamic acidExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Transfusion necessity
Intra- or postoperative transfusion of at least one unit of packed red blood cells
Time frame
Until hospital discharge or 30 days postoperatively, whatever occurs earlierSecondary outcomes
1
Transfusion amount
Number of transfused units of packed red blood cells per patient
Time frame
Until hospital discharge or 30 days postoperatively, whatever occurs earlier2
Blood loss
Estimated intraoperative blood loss
Time frame
From skin incision to suture3
Postoperative complications and mortality
Postoperative complications and mortality assessed according to the Clavien-Dindo scheme
Time frame
Until hospital discharge or 30 days postoperatively, whatever occurs earlier4
Length of hospital stay
Time period from hospital admission to discharge
Time frame
From hospital admission to dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ulrich Ronellenfitsch, MD
Lead sponsor
Martin-Luther-Universität Halle-Wittenberg
Sponsor institution
German Federal Ministry of Education and Research
Collaborator
Coordinating Centre for Clinical Trials Halle
Collaborator
Source ClinicalTrials.gov