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Tranexamic Acid in Breast Esthetic Surgery.

Primary Purpose

Hemorrhage, Bleeding

Status
Recruiting
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Placebo
Tranexamic acid
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: women scheduled for breast esthetic surgery ASA 1 or 2 age >18 and <75 years Exclusion Criteria: BMI <20 or >35 kg/m2 ASA 3 or > 3 medical history of thromboembolism history of hematological disease treatment with aspirin 14 days before the procedure treatment with anticoagulants 5 days before the procedure epilepsy allergy to tranexamic acid coagulation disorders

Sites / Locations

  • Poznan University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Tranexamic acid

Arm Description

Normal saline for intravenous administration.

Tranexamic Acid for intravenous administration.

Outcomes

Primary Outcome Measures

Blood loss volume
Total blood volume loss will be calculated in milliliters.

Secondary Outcome Measures

HBG
Hemoglobin level measured before and 24 hours after surgery
D-dimer
D-dimer level measured before and 24 hours after surgery
Fibrinogen
Fibrinogen level measured before and 24 hours after surgery

Full Information

First Posted
July 6, 2023
Last Updated
October 11, 2023
Sponsor
Poznan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05945680
Brief Title
Tranexamic Acid in Breast Esthetic Surgery.
Official Title
The Effectiveness of Tranexamic Acid in Breast Esthetic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing breast esthetic surgery. This study aims to quantify blood loss during abdominoplasty with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in breast esthetic surgery patients.
Detailed Description
Tranexamic acid (TXA) treatment is increasingly emphasized in plastic surgery because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prevention) and mitigating ongoing hemorrhage. TXA therapy has been principally studied in populations; the results of studies in plastic surgery still need to be improved. Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in various circumstances, primarily involving trauma patients. The investigators designed a randomized placebo-controlled trial comparing TXA dosing before incision for breast esthetic surgery. The purpose is to quantify blood loss during plastic surgery with and without TXA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline for intravenous administration.
Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
Tranexamic Acid for intravenous administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
TXA
Intervention Description
Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.
Primary Outcome Measure Information:
Title
Blood loss volume
Description
Total blood volume loss will be calculated in milliliters.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
HBG
Description
Hemoglobin level measured before and 24 hours after surgery
Time Frame
24 hours after surgery
Title
D-dimer
Description
D-dimer level measured before and 24 hours after surgery
Time Frame
24 hours after surgery
Title
Fibrinogen
Description
Fibrinogen level measured before and 24 hours after surgery
Time Frame
24 hours after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
adult women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women scheduled for breast esthetic surgery ASA 1 or 2 age >18 and <75 years Exclusion Criteria: BMI <20 or >35 kg/m2 ASA 3 or > 3 medical history of thromboembolism history of hematological disease treatment with aspirin 14 days before the procedure treatment with anticoagulants 5 days before the procedure epilepsy allergy to tranexamic acid coagulation disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Małgorzata Domagalska, Ph.D.
Phone
+48 608762068
Email
m.domagalska@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Małgorzata Domagalska, Ph.D.
Organizational Affiliation
Poznań University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Poznan University of Medical Sciences
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata Domagalska, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Tranexamic Acid in Breast Esthetic Surgery.

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