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Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass (PATRY)

Primary Purpose

Hemorrhage, Bleeding

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tranexamic Acid Injection [Cyklokapron]
Sodium chloride 0.9%
Sponsored by
Franciscus Gasthuis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemorrhage focused on measuring Gastric bypass, Tranexamic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary metabolic procedure;
  • Gastric bypass: Roux-en-Y gastric bypass or One-anastomoses gastric bypass;
  • ≥18 years;
  • Good command of the Dutch or English language.

Exclusion Criteria:

  • Patients unwilling to give informed consent;
  • Patients with a medical history of bleeding or VTE (defined as, pulmonary embolism (PE) or deep vein thrombosis (DVT));
  • Patients who use anticoagulants;
  • Arterial bleeding or (iatrogenic) bleeding during the procedure coming from surrounding organs or vascular structures such as the liver or the spleen.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tranexamic acid

    Placebo

    Arm Description

    1500mg Tranexamic acid

    sodium chloride

    Outcomes

    Primary Outcome Measures

    re-intervention rate
    To compare the re-intervention rate due to haemorrhage within 30 days postoperative, after peroperative administration of TXA versus placebo in patients receiving a RYGB or OAGB

    Secondary Outcome Measures

    the use of haemostatic staple devices
    measurement (yes/no). Peroperatively, only on active bleeding a heamostatic staple device will be used. If there is no bleeding no haemostatic staple device will be used.
    the use of fibrin sealant
    measurement (yes/no). Peroperatively, if the staple line is not actively bleeding but is oozing, fibrin sealant is used. If there is no oozing, fibrin sealant is not used.
    blood loss
    blood loss in ml during surgery
    haemoglobin decrease
    haemoglobin decrease postoperative
    heart rate increase
    heart rate increase postoperative
    number of suspicion on haemorrhage
    number of suspicion on haemorrhage for which extra haemoglobin monitoring
    number of suspicion on haemorrhage for which extra haemoglobin monitoring
    number of suspicion on haemorrhage for which extra haemoglobin monitoring
    VTE
    VTE postoperative
    complications rates
    postoperative complications rates
    length of hospital stay
    length of hospital stay
    duration of primary surgery
    duration of primary surgery

    Full Information

    First Posted
    July 12, 2022
    Last Updated
    July 15, 2022
    Sponsor
    Franciscus Gasthuis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05464394
    Brief Title
    Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass
    Acronym
    PATRY
    Official Title
    Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass to Reduce Haemorrhage (PATRY Study): a Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Franciscus Gasthuis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The incidence of bleeding after metabolic surgery seems to increase. The administration of a drug (tranexamic acid) that can reduce bleeding could possibly also reduce bleeding after metabolic surgery. Objective: This study aims to determine whether administration of tranexamic acid before surgery can reduce postoperative bleeding in patients undergoing gastric bypass.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemorrhage, Bleeding
    Keywords
    Gastric bypass, Tranexamic acid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    1524 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic acid
    Arm Type
    Experimental
    Arm Description
    1500mg Tranexamic acid
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    sodium chloride
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid Injection [Cyklokapron]
    Intervention Description
    A set dose of 1500 mg will be used, based on the study population with morbid obesity. It will be administered intravenous dissolved in 100 ml sodium chloride 0.9% in a time frame of 15-30 minutes, with a maximum of 100 mg/min.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium chloride 0.9%
    Other Intervention Name(s)
    Placebo
    Intervention Description
    100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes
    Primary Outcome Measure Information:
    Title
    re-intervention rate
    Description
    To compare the re-intervention rate due to haemorrhage within 30 days postoperative, after peroperative administration of TXA versus placebo in patients receiving a RYGB or OAGB
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    the use of haemostatic staple devices
    Description
    measurement (yes/no). Peroperatively, only on active bleeding a heamostatic staple device will be used. If there is no bleeding no haemostatic staple device will be used.
    Time Frame
    peroperatively
    Title
    the use of fibrin sealant
    Description
    measurement (yes/no). Peroperatively, if the staple line is not actively bleeding but is oozing, fibrin sealant is used. If there is no oozing, fibrin sealant is not used.
    Time Frame
    peroperatively
    Title
    blood loss
    Description
    blood loss in ml during surgery
    Time Frame
    peroperatively
    Title
    haemoglobin decrease
    Description
    haemoglobin decrease postoperative
    Time Frame
    1 day
    Title
    heart rate increase
    Description
    heart rate increase postoperative
    Time Frame
    1 day
    Title
    number of suspicion on haemorrhage
    Description
    number of suspicion on haemorrhage for which extra haemoglobin monitoring
    Time Frame
    30 days
    Title
    number of suspicion on haemorrhage for which extra haemoglobin monitoring
    Description
    number of suspicion on haemorrhage for which extra haemoglobin monitoring
    Time Frame
    30 days
    Title
    VTE
    Description
    VTE postoperative
    Time Frame
    30 days
    Title
    complications rates
    Description
    postoperative complications rates
    Time Frame
    30 days
    Title
    length of hospital stay
    Description
    length of hospital stay
    Time Frame
    30 days
    Title
    duration of primary surgery
    Description
    duration of primary surgery
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary metabolic procedure; Gastric bypass: Roux-en-Y gastric bypass or One-anastomoses gastric bypass; ≥18 years; Good command of the Dutch or English language. Exclusion Criteria: Patients unwilling to give informed consent; Patients with a medical history of bleeding or VTE (defined as, pulmonary embolism (PE) or deep vein thrombosis (DVT)); Patients who use anticoagulants; Arterial bleeding or (iatrogenic) bleeding during the procedure coming from surrounding organs or vascular structures such as the liver or the spleen.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Judith WH Hart, MD
    Phone
    010 - 461 6163
    Ext
    +31
    Email
    j.hart@franciscus.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jan A Apers, MD
    Phone
    010 - 461 6163
    Ext
    +31
    Email
    j.apers@franciscus.nl

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data Statement: The identified individual clinical trial participant-level data, protocols, and the statistical analysis plan will be available upon reasonable request at publication. These data will be available for researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to j.apers@franciscus.nl, and to obtain access, data requestors will need a data access agreement.
    IPD Sharing Time Frame
    Participant-level data, protocols, and the statistical analysis plan will be available upon reasonable request at publication. Within 1 year after the last follow-up.
    IPD Sharing Access Criteria
    upon reasonable request

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