Evaluation of acute normovolemic hemodilution on coagulation during liver surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001282-13-BE

Enrollment

Unknown

Registered

2015-06-04

Start date

2015-06-30

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coagulation during liver surgery Acute normowolemic hemodilution

Interventions

Trade Name: Plasmalyte Pharmaceutical Form: Solution for infusion INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE Concentration unit: g/l gram(s)/litre Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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 1,5) • Anticoagulant therapy. • Preoperative hemoglobin 35.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

bimetra.clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026