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Tracheotomy With and Without Dual Antiplatelet Therapy (PDT and (D)APT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05058469
Recruitment Status : Recruiting
First Posted : September 27, 2021
Last Update Posted : December 8, 2023
Sponsor:
Information provided by (Responsible Party):
Asklepios Neurological Clinic Bad Salzhausen

Study Description
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Brief Summary:

Platelet-inhibiting drugs are often used after vascular interventions. Patients who require such therapies are often critically ill, are treated in intensive care units and often require long-term ventilation. For long-term ventilation a tracheotomy is necessary, which is usually performed as a percutaneous dilatative tracheotomy (PDT). As part of this intervention, there is (theoretically) an increased risk of bleeding/an increased rate of complications in patients with a antiplatelet therapy. In addition, there are various techniques for performing a PDT.

The current study aims to investigate the frequency of bleeding/complications taking into account the technique used in PDT.


Condition or disease Intervention/treatment
Tracheostomy Hemorrhage Device: Tracheotomy

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Safety of Percutaneous Tracheotomies in Intensive Care Patients With and Without Antiplatelet Therapy and Comparison of Two Tracheotomy Techniques
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Group/Cohort Intervention/treatment
Tracheotomy without antiplatelet therapy+technique 1 Device: Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy
Tracheotomy under antiplatelet therapy+technique 1 Device: Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy
Tracheotomy without antiplatelet therapy+technique 2 Device: Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy
Tracheotomy under antiplatelet therapy+technique 2 Device: Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of bleeding during Percutaneous Dilational Tracheostomy (PDT) with and without antiplatelet therapy (AP). [ Time Frame: 3 days ]
    • bleeding (yes/no)
    • intervention (yes/no)
    • decrease (>= 1 g/dl) of hemoglobin (yes/no)
    • number of blood transfusion(s)


Secondary Outcome Measures :
  1. - Does the technique of PDT affect the bleeding rate? - How often are recognizable cartilage pin fractures in the context of a PDT? - Influence of AP and PDT technology on the frequency of need for a blood transfusion? [ Time Frame: 14 days ]
    cartilage pin fractures seen in endoscopy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent Percutaneous Dilational Tracheostomy within the last 5 years.
Criteria

Inclusion Criteria:

  • Patients who underwent Percutaneous Dilational Tracheostomy

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058469


Contacts
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Contact: Dirk Bandorski, MD +496043804212 d.bandorski@asklepios.com

Locations
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Germany
Neurologische Klinik Bad Salzhausen Recruiting
Nidda, Germany, 63667
Contact: Dirk Bandorski, MD    +496043804212    d.bandorski@asklepios.com   
Contact: Jens Allendörfer, MD         
Sponsors and Collaborators
Asklepios Neurological Clinic Bad Salzhausen
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Asklepios Neurological Clinic Bad Salzhausen
ClinicalTrials.gov Identifier: NCT05058469    
Other Study ID Numbers: PDT and (D)APT
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: December 8, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes