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
- Are there results?
- None posted in the registry
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)
Show all 12Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06414031
- Acronym / sponsor ID
- TATRA / TATRA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 892 participants (actual)
- Lead sponsor
- Ulrich Ronellenfitsch, MDUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Coordinating Centre for Clinical Trials Halle
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic AcidIntravenous administration of tranexamic acid (1 g bolus 10 minutes prior to skin incision followed by continuous infusion 125 mg / hour until skin closure) |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidAlso: Tranexamsäure Carinopharm 100mg/mlIntravenous administration | Drug | Tranexamic acid |
| PlaceboAlso: Isotone Kochsalz-Lösung 0,9% InfusionslösungIntravenous administration | Drug | Placebo |
Primary outcome
Transfusion necessity
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Intra- or postoperative transfusion of at least one unit of packed red blood cells
8 secondary outcomes
Transfusion amount
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Blood loss
Time frame: From skin incision to suture
Postoperative complications and mortality
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Length of hospital stay
Time frame: From hospital admission to discharge
Operation time
Time frame: From skin incision to suture
Anesthesia time
Time frame: From anesthesia induction to end of anesthesia
D-dimer levels
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Adverse events
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 39425234Ronellenfitsch 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Ronellenfitsch, MD principal investigator
Medical Faculty of the Martin Luther University Halle-Wittenberg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfusion necessity (time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06414031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.