## Protocol Section
### Identification Module
**NCT ID:** NCT06428682

**Brief Title:** Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

**Official Title:** Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial

#### Organization Study ID Info
**ID:** HSR220370
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
### Status Module
#### Completion Date
**Date:** 2026-05-13

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-13

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-13

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Virginia

#### Responsible Party

**Investigator Affiliation:** University of Virginia

**Investigator Full Name:** John Stranix

**Investigator Title:** Assistant Professor of Plastics Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with ERAS protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as DVT/PE.

### Conditions Module

**Conditions:**

- Breast Cancer

- Blood Loss, Surgical

**Keywords:**

- Autologous breast reconstruction

- Free Flap

- Tranexamic Acid

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA

**Intervention Names:**

- Drug: Tranexamic acid

**Label:** TXA group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TXA group

**Description:** Experimental group will receive TXA intraoperatively (15mg/kg IV, once at beginning of case then re dose at 4hrs if operation goes longer) at the time of their surgery.

**Name:** Tranexamic acid

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo group

**Description:** Control group will receive same volume equivalent of saline intravenously at the time of their surgery.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Post-op day 1 Hemoglobin - Pre-op Hemogobin

**Measure:** Delta Hemoglobin

**Time Frame:** 1 day after surgery

**Description:** Transfusion rate during hospital stay

**Measure:** Transfusion rate

**Time Frame:** Typically 0-72 hours after surgery

#### Secondary Outcomes

**Description:** Thromboembolic event, hematoma, seroma, flap compromise/ failure

**Measure:** Surgical complications

**Time Frame:** 30 days after surgery

**Description:** Total length of stay after surgery

**Measure:** Length of Stay

**Time Frame:** typically 2-4 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center

Exclusion Criteria:

* Subjects with ages \<18 years
* Allergy to TXA
* Subjects who has contraindications to TXA: anyone who has active intravascular thrombosis or anyone with subarachnoid hemorrhage
* Subjects who have anemia (defined as baseline hemoglobin \<8 g/dL
* Subjects who cannot read or understand English
* Subjects who are pregnant

**Gender Based:** True

**Gender Description:** Biological females

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** RHP7GU@uvahealth.org

**Name:** Rachel Park, MD

**Phone:** 5714287278

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charlottesville

**Contacts:**

***Contact 1:***

- **Email:** rhp7gu@hscmail.mcc.virginia.edu

- **Name:** Rachel H Park, MD

- **Phone:** 571-428-7278

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Virginia Medical Center

**State:** Virginia

**Status:** RECRUITING

**Zip:** 22902

#### Overall Officials

**Official 1:**

**Affiliation:** University of Virginia

**Name:** John Stranix, MD

**Role:** PRINCIPAL_INVESTIGATOR

## 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: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M18560

- Name: Blood Loss, Surgical

- Relevance: HIGH

- As Found: Blood Loss, Surgical

- 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
