Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

To assess the incidence of hyperfibrinolysis

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Post-Marketing Requirement study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(B05AA) Blood substitutes and plasma protein fractions
Blood substitutes and plasma protein fractions

Medical condition to be studied

Liver transplant
Population studied

Short description of the study population

Patients undergoing orthotopic liver transplant (OLT) receiving octaplas™ or plasma issued according to institutional standard of care

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Immunocompromised
Hepatic impaired

Estimated number of subjects

43
Study design details

Main study objective

To assess the incidence of hyperfibrinolysis in patients undergoing orthotopic liver transplant (OLT) receiving octaplas™ in comparison to those receiving plasma issued according to institutional standard of care

Outcomes

The incidence of "clinically relevant hyperfibrinolytic events" in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma issued according to institutional standard of care. The incidence of all adverse drug reactions (i.e. transfusion reactions) during the study period among patients receiving octaplas™ in comparison to those receiving plasma issued according to institutional standard of care.

Data analysis plan

This trial was terminated early after FDA released the requirements to conduct the trial. No meaningful results could be obtained based on the limited data obtained.