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Recruiting NCT07094087

Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)

Phase III Interventional Complex Cardiovascular Surgery With Cardiopulmonary Bypass

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BE1116, FFP.
Who it may be relevant to
Registry conditions: Complex Cardiovascular Surgery With Cardiopulmonary Bypass. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, Japan, Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Multicenter, Randomized, Open-label, Controlled Study to Investigate the Efficacy and Safety of 4-Factor Prothrombin Complex Concentrate in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass

Overview

This is a phase 3, multicenter, randomized, open-label, parallel-group, controlled study to assess the efficacy and safety of BE1116 compared with fresh frozen plasma (FFP) in adult participants undergoing complex cardiovascular surgery with CPB. The primary purpose of the study is to compare the efficacy of BE1116 and FFP in correcting coagulation factor deficiencies in bleeding participants undergoing complex cardiovascular surgery with CPB.

Interventions

  • Biological BE1116
    A single dose of BE1116 will be administered by intravenous (IV) infusion intraoperatively.
  • Biological FFP
    A single dose of FFP will be administered as investigational product (IP) by IV infusion intraoperatively.

Primary outcome measures

  • Number of Participants With and Without a Successful Correction of Coagulation Factor Deficiency [Time frame: At Day 1 after IP infusion (30 minutes after the end of infusion)]
Secondary outcome measures (12)
  • Number of Participants With Effective or Not Effective Hemostatic Response from 30 Minutes to 24 Hours After the End of IP Infusion [Time frame: Up to 24 hours after the end of IP infusion]
  • Number of Participants With and Without Successful Correction of Coagulation Factor Deficiency [Time frame: At Day 1 after IP infusion (30 minutes after the end of infusion)]
  • Change in INR from Baseline [Time frame: From baseline (before IP infusion), to 30 minutes, 6 hours, 24 hours, and 48 hours after the end IP infusion]
  • Number of Participants With Effective and Not Effective Hemostatic Response From the Start of IP Infusion to 24 Hours After the Start of IP Infusion [Time frame: Up to 24 hours after the start of IP infusion]
  • Change in Z-Scores for ROTEM EXTEM CT and TEG Reaction Time [Time frame: From baseline (before IP infusion) to 30 minutes and 24 hours after the end IP infusion]
  • Change in Bleeding Severity Scale (BSS) Score From Baseline [Time frame: From baseline (before IP infusion) to 30 minutes after end of IP infusion]
  • Number of Participants in Each Universal Definition for Perioperative Bleeding (UDPB) Class [Time frame: During surgery (Day 1) and on the first postoperative day (Day 2)]
  • Total Number of Units of Allogeneic Blood Products (ABPs) Administered [Time frame: From the start of IP infusion and up to 24 hours and 5 days after surgery]
  • Number of Units of Individual ABPs Administered [Time frame: Up to 24 hours after the start of IP infusion]
  • Volume of Chest Tube Output [Time frame: Up to 24 hours after the end of surgery]
  • Number of Participants Requiring Reoperation for Bleeding and for Other Reasons [Time frame: Up to 30 days after surgery]
  • Duration of Mechanical Ventilation [Time frame: Up to 30 days after surgery]

Eligibility criteria

Inclusion criteria

  • Adult greater than or equal to (≥) 18 years and has provided written informed consent.
  • Undergoing elective complex cardiovascular surgery requiring CPB, including procedures of the thoracic aorta (with or without additional cardiac interventions), aortic valve replacement + coronary artery bypass graft (CABG), complex valve surgeries, mitral valve repair + CABG, and mitral valve replacement + CABG and reoperative CABG. Reoperative procedures are permitted. Excluded surgeries are as follows: heart transplantation, insertion or removal of ventricular assist devices (except for intra-aortic balloon pumps), and acute repair of thoracoabdominal aneurysms.
  • Coagulation factor replacement (ie, 4F-PCC or FFP) is ordered in the operating room for the management of bleeding, in accordance with accepted clinical standards. The following criteria must be met:
  • INR ≥ 1.6 (point-of-care INR testing by Hemochron ≥ 5 to 10 minutes after protamine infusion for heparin reversal). If a participant needs a second dose of protamine, a new INR measurement should be performed to confirm eligibility.
  • Significant microvascular hemorrhage (ie, not due to surgical complications), as defined by a BSS score of ≥ 2.

Exclusion criteria

  • Administration of any systemic hemostatic therapy, such as cryoprecipitate, platelets, FFP, PCC (eg, 4-factor / 3-factor PCC \[4F-PCC / 3F-PCC\]), Factor VIII (FVIII) inhibitor bypassing activity (FEIBA), recombinant activated Factor VIIa (rFVIIa), or other coagulation factor products, in the 24 hours before study surgery, except when FFP is added to the CPB circuit.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • UCLA Health - Ronald Reagan Medical Center — Los Angeles
  • University of Chicago Medicine — Chicago
  • University of Maryland Medical Center (UMMC) — Baltimore
  • North Shore University Hospital — Manhasset
  • University of Cincinnati — Cincinnati
  • OUHSC (University of Oklahoma Health Sciences Center) — Oklahoma City
  • Oregon Health & Sciences University — Portland
  • Thomas Jefferson University Hospital — Philadelphia
  • … and 2 more centers
Canada · 4 centers
  • Kingston Health Science Center — Kingston
  • London Health Sciences Center - University Campus — London
  • University of Toronto - St. Michael's Hospital (SMH) - Keenan Research Centre for Biomedic — Toronto
  • Universite de Montreal-Institut de Cardiologie de Montreal (ICM) Montreal Heart Institute — Montreal
Japan · 3 centers
  • Kyushu University Hospital — Fukuoka
  • National Cerebral and Cardiovascular Center — Suita
  • Sakakibara Heart Institute — Fuchu-shi
Mexico · 1 center
  • Hospital Civil de Guadalajara — Guadalajara

Identifiers

NCT: NCT07094087 · BE1116_3008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗