Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2023-10-17
2025-10-10
Brief Summary
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Detailed Description
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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 abdominoplasty. The purpose is to quantify blood loss during plastic surgery with and without TXA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Normal saline for intravenous administration.
Placebo
100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.
Tranexamic acid
Tranexamic Acid for intravenous administration.
Tranexamic acid
Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.
Interventions
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Placebo
100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.
Tranexamic acid
Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA 1 or 2
* age \>18 and \<75 years
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Poznan University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Małgorzata Domagalska, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Poznań University of Medical Sciences
Locations
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Poznan University of Medical Sciences
Poznan, Poznań, Poland
Countries
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Other Identifiers
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16/2023
Identifier Type: -
Identifier Source: org_study_id
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