NCT02037373

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2.5 years

First QC Date

January 14, 2014

Last Update Submit

March 5, 2018

Conditions

CoagulopathyEndstage Liver Disease

Keywords

intra and post-op coagulopathy in patients undergoing OLT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The safety of octaplas™ in comparison to plasma will be assessed by monitoring the occurrence of adverse drug reactions (i.e., transfusion reactions).

    3 days (perioperative period plus post-operative follow-up)

Study Arms (2)

Octaplas™

Patients treated with Octaplas™ infusion solution for IV administration as prescribed by their treating physician.

Biological: Octaplas™

Plasma

Patients treated with regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products).

Biological: Plasma

Interventions

Octaplas™BIOLOGICAL

Octaplas™ infusion solution for IV administration as prescribed by the treating physician.

Octaplas™
PlasmaBIOLOGICAL

Plasma as prescribed by the treating physician.

Also known as: FFP and other approved plasma products
Plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population will include patients undergoing orthotopic liver transplantation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Octapharma Research Site

Loma Linda, California, 92354, United States

Location

Octapharma Research Site

Philadelphia, Pennsylvania, 19141, United States

Location

Octapharma Research Site

Pittsburgh, Pennsylvania, 15232, United States

Location

Octapharma Research Site

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Wolfgang Frenzel

    International Medical Monitor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 15, 2014

Study Start

August 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

US(4)