HEParin Antagonisation in Transcatheter Aortic Valve Implantation
HepaTAVI
Heparin Influence on Anticoagulation and Perioperative Hemostasis During Transfemoral Transcatheter Aortic Valve Implantation
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2022
CompletedFirst Posted
Study publicly available on registry
June 16, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedJuly 5, 2022
June 1, 2022
7 months
June 13, 2022
June 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary endpoint
Variability of the ROTEM CT(INTEM) after partial heparin reversal
Periprocedural
Study Arms (1)
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
Eligibility Criteria
Patients with severe aortic valve stenosis undergoing transfemoral TAVI as best option
You may qualify if:
- Severe aortic valve Stenosis
- transfemoral TAVI as best therapy option
- unfractioned heparin for periprocedural anticoagulation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
Munich, Bavaria, D80636, Germany
Biospecimen
Blood Samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Mayr
Deutsches Herzzentrum München
- PRINCIPAL INVESTIGATOR
Michael Joner
Deutsches Herzzentrum München
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2022
First Posted
June 16, 2022
Study Start
July 1, 2022
Primary Completion
January 31, 2023
Study Completion
April 1, 2023
Last Updated
July 5, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share