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Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery (Bleeding)

Primary Purpose

Bleeding

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic acid injection
SSI
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bleeding focused on measuring tranexamic acid, Antifibrinolytic agents, bleeding, blood transfusion, thoracic surgery.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux.

Exclusion Criteria:

  • Patients who have had a major complication of surgery other than bleeding requiring revision within 24 hours or a complication related to anesthesia, and cases of non-compliance with the anesthetic protocol are excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group TA

    Group SSI

    Arm Description

    receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.

    Serum saline isotonic (SSI) group: placebo with isotonic saline serum.

    Outcomes

    Primary Outcome Measures

    intraoperative bleeding volume
    The blood volume collected in the suction tanks and the operative drapes intraoperatively

    Secondary Outcome Measures

    The number of red globular caps transfused for each group
    transfusion if hemoglobin less than 7 g / dl
    bleeding volume in the thoracic drains postoperatively
    bleeding volume in the thoracic drains postoperatively every day

    Full Information

    First Posted
    October 1, 2019
    Last Updated
    January 7, 2020
    Sponsor
    University Tunis El Manar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04224116
    Brief Title
    Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery
    Acronym
    Bleeding
    Official Title
    Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    October 2, 2019 (Actual)
    Study Completion Date
    October 2, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Tunis El Manar

    4. Oversight

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

    5. Study Description

    Brief Summary
    Bleeding after thoracic surgery is a major cause of perioperative hemodynamic instability and transfusion requirement, which can lead to a rise of morbidity, mortality and costs. The objective of this study is to evaluate the efficiency of tranexamic acid (TA) in the prevention of perioperative bleeding in thoracic hemorrhagic surgery.
    Detailed Description
    It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified. Two groups of patients: TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. Serum saline isotonic (SSI) group: placebo with isotonic saline serum.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bleeding
    Keywords
    tranexamic acid, Antifibrinolytic agents, bleeding, blood transfusion, thoracic surgery.

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified. Two groups of patients: TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. Serum saline isotonic (SSI) group: placebo with isotonic saline serum.
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    double blind investigation
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group TA
    Arm Type
    Experimental
    Arm Description
    receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
    Arm Title
    Group SSI
    Arm Type
    Placebo Comparator
    Arm Description
    Serum saline isotonic (SSI) group: placebo with isotonic saline serum.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid injection
    Other Intervention Name(s)
    EXACYL
    Intervention Description
    to receive tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
    Intervention Type
    Drug
    Intervention Name(s)
    SSI
    Other Intervention Name(s)
    placebo
    Intervention Description
    Serum Salin isotonic injected
    Primary Outcome Measure Information:
    Title
    intraoperative bleeding volume
    Description
    The blood volume collected in the suction tanks and the operative drapes intraoperatively
    Time Frame
    five hours
    Secondary Outcome Measure Information:
    Title
    The number of red globular caps transfused for each group
    Description
    transfusion if hemoglobin less than 7 g / dl
    Time Frame
    one month
    Title
    bleeding volume in the thoracic drains postoperatively
    Description
    bleeding volume in the thoracic drains postoperatively every day
    Time Frame
    one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Exclusion Criteria: Patients who have had a major complication of surgery other than bleeding requiring revision within 24 hours or a complication related to anesthesia, and cases of non-compliance with the anesthetic protocol are excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tahar Mestiri, Professor
    Organizational Affiliation
    university Manar Tunis
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery

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