Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation

Coagulopathy Clinical Trial

Official title:

Post-Marketing Requirement Study to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02037373
• Other study ID #: LAS-215
• Status: Terminated
• Phase: N/A
• First received: January 14, 2014
• Last updated: March 5, 2018
• Start date: August 2015
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma products).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female age =18 years

• Patient is scheduled to undego orthotopic liver transplantation (OLT)

• Patient has a natural MAYO End-Stage Liver Disease (MELD) score of 15-40

• Patient is willing to give voluntary written informed consent before any study- related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care

Exclusion Criteria:

• Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product

• Patient is known to be IgA deficient with documented antibodies against IgA

• Patient is a planned recipient for a living donor OLT

• Patient has a severe deficiency of Protein S

• Patient is currently participating in an interventional clinical study or has participated in one within 30 days of the date of their OLT

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• End Stage Liver Disease
• Endstage Liver Disease
• Hemostatic Disorders
• Liver Diseases

Intervention

Biological:
• Octaplas™
Octaplas™ infusion solution for IV administration as prescribed by the treating physician.
• Plasma
Plasma as prescribed by the treating physician.

Locations

Country	Name	City	State
United States	Octapharma Research Site	Loma Linda	California
United States	Octapharma Research Site	Nashville	Tennessee
United States	Octapharma Research Site	Philadelphia	Pennsylvania
United States	Octapharma Research Site	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the incidence of hyperfibinolysis in patients undergoing OLT receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products).	The incidence of 'clinically relevant hyperfibrinolytic events' in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma. For this trial a 'clinically relevant hyperfibrinolytic event' is defined as a decrease of at least 7.5% in the maximum amplitude (MA) as measured by the thromboelastography (TEG) or rotational thromboelastography (ROTEM) within 30 minutes after MA is achieved and the event is associated with bleeding requiring intervention.	3 days (perioperative period plus post-operative follow-up)
Secondary	The safety of octaplas™ in comparison to plasma will be assessed by monitoring the occurrence of adverse drug reactions (i.e., transfusion reactions).	The incidence of all adverse drug reactions (i.e., transfusion reactions) during the study period among patients receiving octaplas™ in comparison to standard plasma products.	3 days (perioperative period plus post-operative follow-up)