- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02461329
Comparison of the Effects of Gelatine Versus Balanced Crystalloid Solution for Volume Therapy (Gelaring)
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 Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Milan Kratochvil, MD
- Phone Number: +420532232009
- Email: mkratochvil@fnbrno.cz
Study Contact Backup
- Name: Jozef Klučka, MD
- Phone Number: +420775467052
- Email: jozefklucka@seznam.cz
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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. |
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. |
Volume therapy by Balanced Crystaloid solution solution infusion via intravenous boluses to achieve hemodynamic targets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
perioperative, an expected average of 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood loss
Time Frame: perioperative, an expected average of 2 hours
|
Amount of blood loss during the surgery and in the postoperative period
|
perioperative, an expected average of 2 hours
|
Renal function
Time Frame: 2 days after surgery
|
serum creatinine and blood urea nitrogen will be recorded 48 hours after surgery
|
2 days after surgery
|
Transfusion needs
Time Frame: hospital stay, an expected average of 1 week
|
Number of transfusion units administered during whole hospital stay
|
hospital stay, an expected average of 1 week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
hospital stay, an expected average of 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Milan Kratochvil, MD, FN Brno
- Study Director: Milan Kratochvil, MD, FN Brno
- Study Chair: Roman Gál, Prof, MD, Ph.D, FN Brno
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FN-Brno
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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