Surgical Blood LossPhase 3TATRANCT06414031
Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery
A Phase 3 study testing Tranexamic Acid in people with Surgical Blood Loss and Transfusion-dependent Anemia, run by Ulrich Ronellenfitsch, MD at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Blood Loss, Transfusion-dependent Anemia, Abdomen Disease
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 892 participants
- Where
- 2 sitesGermany
- Study dates
- 17 Jun 2024to 1 Oct 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 study. These comprise measures with a failure rate of <1% per year when used consistently and correctly, such as intravaginal and transdermal combined (oestrogen and progestogen containing) hormonal contraception, injectable and implantable progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).
Who cannot join
- 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 hypoxemia:
- 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)
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- 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 subjects: pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Carl Gustav Carus Dresden
Dresden, Saxony, 01307
University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery
Halle, 06120
About this study
Official title: Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled 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.
- Being tested
- Tranexamic Acid, Placebo
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Tranexamsäure Carinopharm 100mg/ml
Intravenous administration
PlaceboDrug
Also called Isotone Kochsalz-Lösung 0,9% Infusionslösung
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Intravenous administration of tranexamic acid (1 g bolus 10 minutes prior to skin incision followed by continuous infusion 125 mg / hour until skin closure) Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Intravenous administration of placebo (normal saline), 50 ml bolus 10 minutes prior to skin incision followed by continuous infusion of 6.25 ml / hour until skin closure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion necessity
Intra- or postoperative transfusion of at least one unit of packed red blood cells
Measured: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Secondary outcomes (8)
Transfusion amount
Number of transfused units of packed red blood cells per patient
Measured: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Blood loss
Estimated intraoperative blood loss
Measured: From skin incision to suture
Postoperative complications and mortality
Postoperative complications and mortality assessed according to the Clavien-Dindo scheme
Measured: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Length of hospital stay
Time period from hospital admission to discharge
Measured: From hospital admission to discharge
Operation time
Time period from skin incision to suture
Measured: From skin incision to suture
Anesthesia time
Time period from anesthesia induction to end of anesthesia
Measured: From anesthesia induction to end of anesthesia
D-dimer levels
Serum levels of D-dimers
Measured: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Adverse events
Any adverse event attributed to the intervention comprising anaphylaxis, thromboembolic events, acute renal failure, acute heart failure, seizures
Measured: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start17 Jun 2024
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Blood LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 892 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrich Ronellenfitsch, MD
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Coordinating Centre for Clinical Trials Halle
- Responsible party
- Sponsor-investigator, Ulrich Ronellenfitsch, MD, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Ulrich Ronellenfitsch, MD, Principal investigator, Medical Faculty of the Martin Luther University Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414031
- Sponsor's protocol ID
- TATRA
- Other IDs
- 01KG2305, 2023-509970-43-01, 2023
- Acronym
- TATRA
- Status last verified
- Oct 2026
- First submitted
- 10 May 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Ronellenfitsch U, Kestel A, Klose J, Rebelo A, Bucher M, Ebert D, Mikolajczyk R, Wienke A, Kegel T, Hering J, Haiduk C, Richter M, Steighardt J, Grohmann E, Otto L, Kleeff J. Tranexamic Acid for reduction of intra- and postoperative TRansfusion requirements in elective Abdominal surgery (TATRA): study protocol for an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized superiority trial with two parallel groups. Trials. 2024 Oct 19;25(1):695. doi: 10.1186/s13063-024-08541-8.
PubMed 39425234