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Algorithmic Protamine Dosing for Reversal of Heparin After Cardiopulmonary Bypass

NCT03532594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2020-06-23

No results posted yet for this study

Summary

The PRODOSE trial is investigating a bespoke pharmacokinetic algorithm that calculates a tailored dose of protamine, required after cardiopulmonary bypass to reverse the action of heparin, based on individual patients and their actual bypass time.

The PRODOSE trial aims to demonstrate that the algorithm can be used to define a protamine dose that will more reliably return coagulation parameters to pre-heparin levels as well as decreasing the risk of post-operative bleeding and transfusion.

The trial aims to recruit 200 patients who will be randomised to either a bespoke or standard dose of protamine. The randomisation ratio will be 1:1 in the first instance but the trial uses an adaptive design and an interim analysis will be conducted after 100 patients have been randomised. The randomisation ratio could then be updated after the interim analysis to favour a superior arm whilst preserving statistical power levels.

Conditions

Interventions

PROCEDURE

PRODOSE Algorithm

Protamine administered according to PRODOSE algorithm

PROCEDURE

Standard Care

Protamine administered according to Standard Care

Sponsors & Collaborators

  • Austin Health

    collaborator OTHER_GOV

  • Papworth Hospital NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Florian Falter, FRCA · Royal Papworth Hospital NHS Foundation Trust

  • Lachlan Miles, FRCA · Austin Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2019-10-30
Completion
2020-01-30

Countries

  • United Kingdom

Study Locations

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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 NCT03532594 on ClinicalTrials.gov