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RAPID: Documentation of the Efficacy of Desmopressin Within the Context of Surgical Procedures

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02368730
Collaborator
(none)
23
Enrollment
1
Location
13
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this non-interventional multicentre, prospective, observational cohort study, the efficacy of desmopressin is evaluated in patients with platelet dysfunction due to acetylsalicylic acid or cox-1-inhibitors within the context of surgical procedures.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
23 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Documentation of the Efficacy of Desmopressin (MINIRIN Parenteral 4 Microgram/ml Solution for Injection) Within the Context of Surgical Procedures
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
desmopressin

Treatment according to standard clinical practice.

Drug: desmopressin
Other Names:
  • Minirin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in platelet function pre- and post-administration of desmopressin [From baseline up to 7 days]

      As measured by Platelet Function Analyzer (PFA) 100/200

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Pre-, peri- or postoperative treatment with a standard dose of desmopressin as a result of platelet dysfunction (disturbance of blood platelet function) due to treatment with acetylsalicylic acid or cox-1-inhibitor.

    • Decision on the therapy with MINIRIN parenteral 4 Microgram/ml solution for injection has already been made independently by the physician beforehand

    • The patients (≥ 18 years) have been informed about the non-interventional study and have given their written consent for participation

    Exclusion Criteria:

    • Participation in a clinical trial

    • Treatment with acetylsalicylic acid for cardiovascular indications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité - Universitätsmedizin Berlin (there may be other sites in this country) Berlin Germany

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Clinical Development Support, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02368730
    Other Study ID Numbers:
    • 000149
    First Posted:
    Feb 23, 2015
    Last Update Posted:
    Jun 2, 2017
    Last Verified:
    Jun 1, 2017
    Additional relevant MeSH terms:
    Deamino Arginine Vasopressin

    Study Results

    No Results Posted as of Jun 2, 2017