HEParin Antagonisation in Transcatheter Aortic Valve Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Stenosis Transcatheter Aortic Valve Implantation Protamine Sulfate Overdose

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No