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

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ClinicalTrials.gov Identifier: NCT02461329
Recruitment Status : Unknown
Verified June 2015 by Kratochvil Milan, MD, Brno University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
IBA - Masaryk University Institute of biostatistics and analyses
Information provided by (Responsible Party):
Kratochvil Milan, MD, Brno University Hospital

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).

Condition or disease Intervention/treatment Phase
Hemorrhage, Surgical Hip Replacement, Total Thrombocytopathy Drug: Gelofusine® B. Braun Drug: Ringerfundin ® B. Braun Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin

Arm Intervention/treatment
Experimental: Gelatine solution

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.

Drug: Gelofusine® B. Braun
Volume therapy by Gelatine solution infusion via intravenous boluses to achieve hemodynamic targets

Experimental: Balanced Crystaloid solution

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.

Drug: Ringerfundin ® B. Braun
Volume therapy by Balanced Crystaloid solution solution infusion via intravenous boluses to achieve hemodynamic targets




Primary Outcome Measures :
  1. Change of coagulation status and platelet function [ Time Frame: perioperative, an expected average of 2 hours ]
    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 :
  1. Blood loss [ Time Frame: perioperative, an expected average of 2 hours ]
    Amount of blood loss during the surgery and in the postoperative period

  2. Renal function [ Time Frame: 2 days after surgery ]
    serum creatinine and blood urea nitrogen will be recorded 48 hours after surgery

  3. Transfusion needs [ Time Frame: hospital stay, an expected average of 1 week ]
    Number of transfusion units administered during whole hospital stay


Other Outcome Measures:
  1. Perioperative complications [ Time Frame: hospital stay, an expected average of 1 week ]
    Investigators will review all records after patient dismission and search for any complications related to medical care



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461329


Contacts
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Contact: Milan Kratochvil, MD +420532232009 mkratochvil@fnbrno.cz
Contact: Jozef Klučka, MD +420775467052 jozefklucka@seznam.cz

Sponsors and Collaborators
Kratochvil Milan, MD
IBA - Masaryk University Institute of biostatistics and analyses
Investigators
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Principal Investigator: Milan Kratochvil, MD FN Brno
Study Director: Milan Kratochvil, MD FN Brno
Study Chair: Roman Gál, Prof, MD, Ph.D Fn Brno

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Responsible Party: Kratochvil Milan, MD, Research coordinator, Brno University Hospital
ClinicalTrials.gov Identifier: NCT02461329     History of Changes
Other Study ID Numbers: FN-Brno
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Keywords provided by Kratochvil Milan, MD, Brno University Hospital:
Hip Replacement, Total
Gelatine solution
Balanced Crystaloid Solution
Volume therapy
Platelet aggregation
Additional relevant MeSH terms:
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Blood Platelet Disorders
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Hematologic Diseases
Intraoperative Complications
Polygeline
Pharmaceutical Solutions
Plasma Substitutes
Blood Substitutes