search
Back to results

Comparison of the Effects of Gelatine Versus Balanced Crystalloid Solution for Volume Therapy (Gelaring)

Primary Purpose

Hemorrhage, Surgical, Hip Replacement, Total, Thrombocytopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gelofusine® B. Braun
Ringerfundin ® B. Braun
Sponsored by
Kratochvil Milan, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage, Surgical focused on measuring Hip Replacement, Total, Gelatine solution, Balanced Crystaloid Solution, Volume therapy, Platelet aggregation

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient scheduled for elective hip replacement surgery
  • age between 19-85 years
  • signed informed consent

Exclusion Criteria:

  • informed consent not signed
  • traumatic hip fracture
  • anemia (hemoglobin level < 100 g/l)
  • allergy to study drug and/or multiple allergies
  • chronic heart failure with LVEF < 30%
  • shock states
  • coagulopathy
  • thrombocytopenia
  • thrombocytopathy
  • chronic kidney disease with oliguria
  • chronic antiplatelet drug medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Gelatine solution

    Balanced Crystaloid solution

    Arm Description

    Gelofusine will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease). The blood pressure and heart rate before and after fluid challenge will be recorded.

    Ringerfundin will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease). The blood pressure and heart rate before and after fluid challenge will be recorded.

    Outcomes

    Primary Outcome Measures

    Change of coagulation status and platelet function
    Before and after the surgery (in OR) the investigator will obtain a blood sample from subject, standard coagulation test will be performed (INR, PT, aPTT, thrombin time), the investigator will perform ROTEM tests: EXTEM, INTEM and FIBTEM assay and blood sample will be tested for thrombocyte function - aggregation with ADP, collagen, epinephrine, TRAP - thrombin receptor-activated peptide.

    Secondary Outcome Measures

    Blood loss
    Amount of blood loss during the surgery and in the postoperative period
    Renal function
    serum creatinine and blood urea nitrogen will be recorded 48 hours after surgery
    Transfusion needs
    Number of transfusion units administered during whole hospital stay

    Full Information

    First Posted
    April 16, 2015
    Last Updated
    June 2, 2015
    Sponsor
    Kratochvil Milan, MD
    Collaborators
    IBA - Masaryk University Institute of biostatistics and analyses
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02461329
    Brief Title
    Comparison of the Effects of Gelatine Versus Balanced Crystalloid Solution for Volume Therapy
    Acronym
    Gelaring
    Official Title
    Comparison of the Effects of Gelatine (Gelofusine ® B. Braun) Versus Crystalloid Solution (Ringerfundin ® B. Braun) for Volume Therapy on Coagulation, Thrombocyte Function and Thrombelastometry (ROTEM ®), in Elective Hip Replacement Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kratochvil Milan, MD
    Collaborators
    IBA - Masaryk University Institute of biostatistics and analyses

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to determine whether volume therapy with a solution of gelatine has negative impact on coagulation, platelet function, renal function in comparison with crystaloid solution (Ringerfundin).
    Detailed Description
    After obtaining the research ethics committee approval, 50 patients, undergoing elective surgery for hip replacement will be included. The informed consent must be signed prior to randomization. After arriving to the operation theatre, the patients informed consent and inclusion and exclusion criteria will be reviewed. Afterwards, the patients will be randomized in one of two groups. Prior to the anaesthesia induction, blood for the thrombocyte function test, coagulation tests and thrombelastometry wil be drawn via a metal cannula. A large bore peripheral venous cannula (G18 or more) will be introduced. In case of a ASA status of III and higher based on cardiovascular morbidity an arterial catheter via the radial artery for invasive blood pressure monitoring will be introduced. Urinary catheter will be introduced to monitor intraoperative diuresis. A continuous crystalloid infusion n a dose of 5 ml/kg/hour will be administered for basal fluid substitution. The volume replacement using blinded gelatine/crystalloid solution will be performed via fluid challenge (repeated 250 ml fluid boluses during a 5 minute interval) to hemodynamic targets (increase in blood pressure, decrease in heart rate), in case of a decrease of MAP to 65 mm Hg (16) or to 70 mmHg in preexisting hypertension. The hemodynamic variables before and after fluid challenge will be exactly recorded. In case the patient hemodynamics does dot respond to a fluid challenge, or in case of a drop of blood pressure to less than 55 mmHg, a bolus of 5-10 mg of ephedrine (repeatedly) will be administered. Further recorded variables will be: blood loss (suctioning, sponges), diuresis, number of transfusions administered. Repetitive hemoglobin concentration tests using the HemoCue 201+ device will be performed and an intraoperative blood transfusion trigger of 90 g/l of hemoglobin concentration will be used, 100 g/l in case of a patient with chronic cardiovascular or respiratory disease (5). After reaching the blood loss of 1000 ml, blood samples will be drawn for laboratory hemoglobin concentration and coagulation testing. The trigger for platelet transfusion will be a thrombocyte count of less than 50000 x 109, or sings of platelet dysfunction on thrombelastometry. Tranexamic acid will be administered in case of signs of fibrinolysis on thrombelastometry or in case of life threatening bleeding. At the end of surgery, a second blood sample for platelet function test, thrombelastometry, full blood count and standard coagulation tests will be drawn. The amount of blinded study infusion, continuous crystalloid solution, transfusions and ephedrine administered, diuresis and blood loss will be recorded. Blood urea and creatinine, diuresis, coagulations and full blood count will be recorded postoperatively. Hospital and ICU length of stay, hospital and 90-day mortality will be followed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemorrhage, Surgical, Hip Replacement, Total, Thrombocytopathy
    Keywords
    Hip Replacement, Total, Gelatine solution, Balanced Crystaloid Solution, Volume therapy, Platelet aggregation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Gelatine solution
    Arm Type
    Experimental
    Arm Description
    Gelofusine will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease). The blood pressure and heart rate before and after fluid challenge will be recorded.
    Arm Title
    Balanced Crystaloid solution
    Arm Type
    Experimental
    Arm Description
    Ringerfundin will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease). The blood pressure and heart rate before and after fluid challenge will be recorded.
    Intervention Type
    Drug
    Intervention Name(s)
    Gelofusine® B. Braun
    Intervention Description
    Volume therapy by Gelatine solution infusion via intravenous boluses to achieve hemodynamic targets
    Intervention Type
    Drug
    Intervention Name(s)
    Ringerfundin ® B. Braun
    Intervention Description
    Volume therapy by Balanced Crystaloid solution solution infusion via intravenous boluses to achieve hemodynamic targets
    Primary Outcome Measure Information:
    Title
    Change of coagulation status and platelet function
    Description
    Before and after the surgery (in OR) the investigator will obtain a blood sample from subject, standard coagulation test will be performed (INR, PT, aPTT, thrombin time), the investigator will perform ROTEM tests: EXTEM, INTEM and FIBTEM assay and blood sample will be tested for thrombocyte function - aggregation with ADP, collagen, epinephrine, TRAP - thrombin receptor-activated peptide.
    Time Frame
    perioperative, an expected average of 2 hours
    Secondary Outcome Measure Information:
    Title
    Blood loss
    Description
    Amount of blood loss during the surgery and in the postoperative period
    Time Frame
    perioperative, an expected average of 2 hours
    Title
    Renal function
    Description
    serum creatinine and blood urea nitrogen will be recorded 48 hours after surgery
    Time Frame
    2 days after surgery
    Title
    Transfusion needs
    Description
    Number of transfusion units administered during whole hospital stay
    Time Frame
    hospital stay, an expected average of 1 week
    Other Pre-specified Outcome Measures:
    Title
    Perioperative complications
    Description
    Investigators will review all records after patient dismission and search for any complications related to medical care
    Time Frame
    hospital stay, an expected average of 1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient scheduled for elective hip replacement surgery age between 19-85 years signed informed consent Exclusion Criteria: informed consent not signed traumatic hip fracture anemia (hemoglobin level < 100 g/l) allergy to study drug and/or multiple allergies chronic heart failure with LVEF < 30% shock states coagulopathy thrombocytopenia thrombocytopathy chronic kidney disease with oliguria chronic antiplatelet drug medications
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Milan Kratochvil, MD
    Phone
    +420532232009
    Email
    mkratochvil@fnbrno.cz
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jozef Klučka, MD
    Phone
    +420775467052
    Email
    jozefklucka@seznam.cz
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Milan Kratochvil, MD
    Organizational Affiliation
    FN Brno
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Milan Kratochvil, MD
    Organizational Affiliation
    FN Brno
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Roman Gál, Prof, MD, Ph.D
    Organizational Affiliation
    Fn Brno
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of the Effects of Gelatine Versus Balanced Crystalloid Solution for Volume Therapy

    We'll reach out to this number within 24 hrs