NCT02577614

Brief Summary

The purpose of this pilot study is to evaluate the feasibility of the prophylactic administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to demonstrate the potential role of FEIBA administration in reducing the need for allogeneic transfusion to treat refractory coagulopathy in high risk patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3.8 years

First QC Date

September 24, 2015

Last Update Submit

July 13, 2020

Conditions

Cardiovascular Disease

Keywords

Cardiopulmonary BypassAortic Valve RepairCoronary Re-ImplantationDeep Hypothermic Circulatory ArrestFactor VIII Inhibitor Bypass ActivityTransfusion

Outcome Measures

Primary Outcomes (1)

  • Volume of blood products transfused (mL)

    -Cumulative volume of blood products transfused, defined as the volume in mL of packed red blood cells, fresh frozen plasma, and platelets, after the administration of the study drug (mL)

    30 days

Secondary Outcomes (4)

  • Number of thrombotic or thromboembolic events

    30 days

  • Number of patients with post-operative bleeding requiring surgical hemostasis

    30 days

  • Duration of post-operative ventilation, ICU and hospital length of stay

    30 days

  • Number of deaths

    30 days

Study Arms (2)

FEIBA

EXPERIMENTAL

Single dose of commercially available FEIBA

Drug: FEIBA

Normal Saline

PLACEBO COMPARATOR

Single dose of NaCl 0.9%

Drug: Normal Saline

Interventions

FEIBADRUG

Administration of FEIBA after cardiopulmonary bypass

Also known as: Anti-Inhibitor Coagulant Complex
FEIBA
Normal SalineDRUG

Administration of placebo after cardiopulmonary bypass

Also known as: NaCl 0.9%
Normal Saline

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Elective aortic or aortic valve procedures, coronary re-implantation (Bentall) with cardiopulmonary bypass, and/or deep hypothermic circulatory arrest.
  • Written informed consent

You may not qualify if:

  • Contraindications to the administration of FIEBA or known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components
  • Disseminated intravascular coagulation (DIC)
  • Acute thrombosis or embolism, including myocardial infarction
  • Pregnant women
  • Decisionally impaired adults
  • Prisoners
  • Expressed unwillingness or are otherwise deemed unable to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Sera VA, Stevens AE, Song HK, Rodriguez VM, Tibayan FA, Treggiari MM. Factor VIII inhibitor bypass activity (FEIBA) for the reduction of transfusion in cardiac surgery: a randomized, double-blind, placebo-controlled, pilot trial. Pilot Feasibility Stud. 2021 Jul 2;7(1):137. doi: 10.1186/s40814-021-00873-5.

    PMID: 34215339DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

anti-inhibitor coagulant complexSaline SolutionSodium Chloride

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Director

Study Record Dates

First Submitted

September 24, 2015

First Posted

October 16, 2015

Study Start

February 1, 2016

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

US(1)