Hemorrhage, Surgical Clinical Trial
— GelaringOfficial 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
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).
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kratochvil Milan, MD | IBA - Masaryk University Institute of biostatistics and analyses |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Perioperative complications | 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 | Yes |
Primary | 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. | perioperative, an expected average of 2 hours | Yes |
Secondary | Blood loss | Amount of blood loss during the surgery and in the postoperative period | perioperative, an expected average of 2 hours | Yes |
Secondary | Renal function | serum creatinine and blood urea nitrogen will be recorded 48 hours after surgery | 2 days after surgery | Yes |
Secondary | Transfusion needs | Number of transfusion units administered during whole hospital stay | hospital stay, an expected average of 1 week | Yes |
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