MedTrace Logo

Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass.

NCT06154018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-05-31

No results posted yet for this study

Summary

Protamine is routinely used as a heparin reversal agent in cardiac surgery. However, its use may be associated with adverse events, while protamine excess may have additional anti-coagulant affect. Although guidelines advise towards a diminished reversal ratio, clinical practice remain heterogenic. The purpose of this study is to compare two different reversal ratios (0.6:1 και 0.8:1) of total heparin regarding the Activated Clotting Time (ACT), viscoelastic assays (Clot-Pro) and clinical hemorrhage.

A baseline ACT value and Clot Pro tests will be obtained prior to the operation start. After the initial reversal, ACT, Clot Pro tests will be conducted again. Coagulation factors are administrated according to Clot Pro results, and in case of ongoing clinical hemorrhage and any indication of heparin excess in the measured values, another 25mg of protamine is administrated, while tests are repeated.

Conditions

  • Cardiac Surgery
  • CAD
  • Valve Heart Disease
  • Coagulation Disorder

Interventions

DRUG

Protamin

ACT and Clot- Pro test will be ran after initial and possible next protamine administrations

Sponsors & Collaborators

  • University of Ioannina

    lead OTHER

Principal Investigators

  • Evangelia Samara, Md, PhD · University of Ioannina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-18
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Greece

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 NCT06154018 on ClinicalTrials.gov