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Trial of PCC Versus FFP in Patients Undergoing Heart Surgery

NCT03715348 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-11-17

No results posted yet for this study

Summary

The PROPHESY trial is a single centre pilot trial investigating Fresh Frozen Plasma (FFP) or Prothrombin Complex Concentrate (PCC) treatment for patients who are bleeding during cardiac surgery, and who are NOT receiving a vitamin K antagonist agent (e.g. warfarin).

This pilot study will investigate the feasibility of delivering the different components of the trial, so that investigators can determine if it's feasible to move to a future large trial that will aim to compare the efficacy and safety of FFP versus PCC in adult patients who are actively bleeding during cardiac surgery.

Conditions

Interventions

DRUG

Prothrombin Complex Concentrate (PCC)

PCC is a blood product produced through pooling of thousands of human plasmas, which is then treated to inactivate enveloped viruses. From the pooled plasma, vitamin K dependent clotting factors (factors II, VII, IX and X, and protein C and protein S), are selected to produce the concentrated form called PCC.

BIOLOGICAL

Fresh Frozen Plasma

Fresh Frozen Plasma a blood component manufactured from whole blood collection.

Sponsors & Collaborators

  • British Heart Foundation

    collaborator OTHER

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Laura Green, MBBS MsC MD(Res) MRCP FRCPath · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-01-29
Completion
2020-01-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715348 on ClinicalTrials.gov