HEParin Antagonisation in Transcatheter Aortic Valve Implantation (HepaTAVI)

Heparin Influence on Anticoagulation and Perioperative Hemostasis During Transfemoral Transcatheter Aortic Valve Implantation

Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation; Protamine Sulfate Overdose

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Patrick Mayr, MD; Phone Number: +498912180; Email: mayrp@dhm.mhn.de
• Study Contact Backup: Name: Michael Joner, Prof; Phone Number: +498912180; Email: joner@dhm.mhn.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, D80636
      • Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
      • Principal Investigator: Patrick Mayr, MD
      • Contact: Michael Joner, Prof; Phone Number: +498912180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic valve stenosis undergoing transfemoral TAVI as best option

Description

Inclusion Criteria:

• Severe aortic valve Stenosis
• transfemoral TAVI as best therapy option
• unfractioned heparin for periprocedural anticoagulation

Exclusion Criteria:

• known hypersensitivity /allergy to unfractioned heparin or protamine
• acute systemic infection
• pre procedural started and ongoing intravenous therapy with unfractioned heparin
• severe periprocedural adverse event with the need for emergency surgery (with or with our CPB)
• refusal of the patient to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing transfemoral TAVI; Patients receiving 125 U/kg unfractioned heparin for periprocedural anticoagulation and 500U Protamine / 1000U Heparin at the end of the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint	Variability of the ROTEM CT(INTEM) after partial heparin reversal	Periprocedural

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Principal Investigator: Patrick Mayr, Deutsches Herzzentrum München; Principal Investigator: Michael Joner, Deutsches Herzzentrum München

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): January 31, 2023
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (ACTUAL): June 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Anticoagulation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: GE IDE No. T00222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO