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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Thrombelastome

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 Summary: 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 blo
Sponsor: Kratochvil Milan, MD

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood loss [ Time Frame: perioperative, an expected average of 2 hours ]
    Amount of blood loss during the surgery and in the postoperative period
  • Renal function [ Time Frame: 2 days after surgery ]
    serum creatinine and blood urea nitrogen will be recorded 48 hours after surgery
  • Transfusion needs [ Time Frame: hospital stay, an expected average of 1 week ]
    Number of transfusion units administered during whole hospital stay


Original Secondary Outcome: Same as current

Information By: Brno University Hospital

Dates:
Date Received: April 16, 2015
Date Started: May 2015
Date Completion: December 2016
Last Updated: June 2, 2015
Last Verified: June 2015