Evaluation of acute normovolemic hemodilution on coagulation during liver surgery.
- Conditions
- Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]coagulation during liver surgeryAcute normowolemic hemodilution
- Registration Number
- EUCTR2015-001282-13-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Adult = 18 years (Female or Male)
•Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
•Scheduled for liver surgery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
•Active coronary artery disease.
•History of cerebrovascular disease.
•History of congestive heart failure.
•Hemodynamic instable patients.
•Renal dysfunction (creatinine > 2 mg/dL)
•History of coagulopathy.
•Coagulopathy (Platelet count < 100.000 / mm3 or INR > 1,5)
•Anticoagulant therapy.
•Preoperative hemoglobin < 12 g/dL.
•Documented allergy of the IV fluids used in the protocol.
•Morbidly obese patients with BMI > 35.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of acute normovolemic hemodilution with different fluids during liver surgery on coagulation using standard coagulation test, thromboelastography and glasbeat sonoclot.;Secondary Objective: Not applicable;Primary end point(s): coagulopathy during Acute Normowolemic Hemodilution (ANH), defined as a prolongation of the R-value on the tromboelastogram. ;Timepoint(s) of evaluation of this end point: end of ANH
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable