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Coagulation effect of four common plasma volume expanders

Coagulation effect of four common plasma volume expanders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000729-24-SE
Enrollment
Unknown
Registered
2007-02-20
Start date
2007-05-15
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Fluid/Plasma substitution during total hip replacement

Interventions

Trade Name: Macrodex Product Name: Macrodex Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Spiri (isobenzofuran-1(3H),9'-[9H] xanthene]-3-ett,3'6' dihydrox, disodium salt Concentration

Sponsors

University Hospital Linköping
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Consecutive patients scheduled for total hip relacement 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Alergic reactions to any of the IMP´s, diabetes and major cardiopulmonary disease

Design outcomes

Primary

MeasureTime frame
Main Objective: Study influence of four common volume expanders on operative and postoperative bleeding and on coagulation (InTEG)(clot formation). ;Secondary Objective: influence on other coagulation tests depending on volume expander chosen;Primary end point(s): Endpoint after 80 patients (20 in each study group) Evaluation of the bleeding, coagulation factors and measurements taken. Hemoglobine, albumine, InTEG, Thrombine complex, Anti-thrombine complex, D-dimer, Soluble P-selectine, v Willibrand factor.—

Countries

Sweden

Outcome results

None listed

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