## Protocol Section
### Identification Module
**NCT ID:** NCT06414031

**Acronym:** TATRA

**Brief Title:** Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

**Official Title:** Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial

#### Organization Study ID Info
**ID:** TATRA
#### Organization
**Class:** OTHER
**Full Name:** Martin-Luther-Universität Halle-Wittenberg
### Status Module
#### Completion Date
**Date:** 2025-11-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-11-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** German Federal Ministry of Education and Research

**Class:** UNKNOWN

**Name:** Coordinating Centre for Clinical Trials Halle

#### Lead Sponsor

**Class:** OTHER

**Name:** Ulrich Ronellenfitsch, MD

#### Responsible Party

**Investigator Affiliation:** Martin-Luther-Universität Halle-Wittenberg

**Investigator Full Name:** Ulrich Ronellenfitsch, MD

**Investigator Title:** Professor of Evidence-based Abdominal Surgical Oncology

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

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.

### Conditions Module

**Conditions:**

- Surgical Blood Loss

- Transfusion-dependent Anemia

- Abdomen Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 850

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intravenous administration of tranexamic acid (1 g bolus 10 minutes prior to skin incision followed by continuous infusion 125 mg / hour until skin closure)

**Intervention Names:**

- Drug: Tranexamic Acid

**Label:** Tranexamic acid

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Tranexamic acid

**Description:** Intravenous administration

**Name:** Tranexamic Acid

**Other Names:**

- Tranexamsäure Carinopharm 100mg/ml

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Intravenous administration

**Name:** Placebo

**Other Names:**

- Isotone Kochsalz-Lösung 0,9% Infusionslösung

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Intra- or postoperative transfusion of at least one unit of packed red blood cells

**Measure:** Transfusion necessity

**Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier

#### Secondary Outcomes

**Description:** Number of transfused units of packed red blood cells per patient

**Measure:** Transfusion amount

**Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier

**Description:** Estimated intraoperative blood loss

**Measure:** Blood loss

**Time Frame:** From skin incision to suture

**Description:** Postoperative complications and mortality assessed according to the Clavien-Dindo scheme

**Measure:** Postoperative complications and mortality

**Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier

**Description:** Time period from hospital admission to discharge

**Measure:** Length of hospital stay

**Time Frame:** From hospital admission to discharge

**Description:** Time period from skin incision to suture

**Measure:** Operation time

**Time Frame:** From skin incision to suture

**Description:** Time period from anesthesia induction to end of anesthesia

**Measure:** Anesthesia time

**Time Frame:** From anesthesia induction to end of anesthesia

**Description:** Serum levels of D-dimers

**Measure:** D-dimer levels

**Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier

**Description:** Any adverse event attributed to the intervention comprising anaphylaxis, thromboembolic events, acute renal failure, acute heart failure, seizures

**Measure:** Adverse events

**Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age 18 years or above
2. Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy
3. Adequate renal function with serum creatinine \<250 µmol/L (2.82 mg/dL)
4. Written informed consent obtained before randomization
5. 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).

Exclusion Criteria:

1. 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.
2. Thrombocytopenia with platelets \<60 x 109 /L
3. Confirmed bleeding disorder with the need for specific preventive perioperative treatment (e.g., factor deficiency with the need of perioperative substitution)
4. A priori refusal of blood transfusions
5. Confirmed thrombophilia with a pertinent need for perioperative anticoagulation
6. Allergy / hypersensitivity to tranexamic acid
7. Recent (\<30 days) thromboembolic event
8. History of medically confirmed convulsions
9. In female subjects: pregnancy or lactation

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ulrich.ronellenfitsch@uk-halle.de

**Name:** Ulrich Ronellenfitsch, MD

**Phone:** +493455572327

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Halle (Saale)

**Contacts:**

***Contact 1:***

- **Email:** ulrich.ronellenfitsch@uk-halle.de

- **Name:** Ulrich Ronellenfitsch, MD

- **Phone:** +49-345-5572327

- **Role:** CONTACT

**Country:** Germany

**Facility:** University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery

**Zip:** 06120

#### Overall Officials

**Official 1:**

**Affiliation:** Medical Faculty of the Martin Luther University Halle-Wittenberg

**Name:** Ulrich Ronellenfitsch, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006470

- Term: Hemorrhage

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007431

- Term: Intraoperative Complications

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M4070

- Name: Anemia

- Relevance: LOW

- As Found: Unknown

- ID: M18560

- Name: Blood Loss, Surgical

- Relevance: HIGH

- As Found: Surgical Blood Loss

- ID: M10465

- Name: Intraoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016063

- Term: Blood Loss, Surgical

### Intervention Browse Module - Ancestors

- ID: D000000933

- Term: Antifibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000006490

- Term: Hemostatics

- ID: D000003029

- Term: Coagulants

### Intervention Browse Module - Browse Branches

- Abbrev: Coag

- Name: Coagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M16902

- Name: Tranexamic Acid

- Relevance: HIGH

- As Found: Stage IV

- ID: M4252

- Name: Antifibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: M6259

- Name: Coagulants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014148

- Term: Tranexamic Acid

### Misc Info Module

- Version Holder: 2024-05-31
