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

NCT06154018 | Completed

• 1 other identifier: 179/23-2-2023
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiac surgery; heparin; protamin; coagulopathy; coagulopathy, viscoelastic tests

Outcome Measures

Primary Outcomes (2)

• Activated Clotting Time (in seconds)

  ACT values after heparin reversal

  Intraoperatively

• Viscoelastic testing

  CT-HI/CT-IN TEST values ratio after heparin reversal

  Intraoperatively

Secondary Outcomes (5)

• Transfusion

  Intraoperatively and up to 24 hours postoperatively

• Clotting factors

  Intraoperatively and up to 24 hours postoperatively

• Postoperative hemorrhage

  24 hours postoperatively

• ICU LOS

  Up to 30 days

• Changes in ClotPro values in EX, FIB, IN and HI tests

  intraoperatively

Study Arms (2)

0.8:1

ACTIVE COMPARATOR

This arm will receive an initial administration of 0.8mg of protamine per 100IU of totally given heparin.

Drug: Protamin

0.6:1

ACTIVE COMPARATOR

This arm will receive an initial administration of 0.6mg of protamine per 100IU of totally given heparin.

Drug: Protamin

Interventions

Protamin DRUG

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

Also known as: viscoelastic testing (Clot-Pro), ACT

0.6:1; 0.8:1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Agreement to participate
• Scheduled for elective cardiac surgery on cardiopulmonary by-pass (CPB)

You may not qualify if:

• Age \<18 years.
• No consent
• Known allergy to heparin or protamine
• History of Heparin Induced Thrombocytopenia (HIT)
• Off pump surgery

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

Location

MeSH Terms

Conditions

Heart Valve Diseases; Hemostatic Disorders

Interventions

somatostatin, protamine zinc-

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Evangelia Samara, Md, PhD

  University of Ioannina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: RCT

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: December 1, 2023
• Study Start: March 18, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)