NCT02368730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

February 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

February 16, 2015

Last Update Submit

June 1, 2017

Conditions

Platelet Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in platelet function pre- and post-administration of desmopressin

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

    From baseline up to 7 days

Study Arms (1)

desmopressin

Treatment according to standard clinical practice.

Drug: desmopressin

Interventions

desmopressinDRUG
Also known as: Minirin
desmopressin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospital doctors specialised in anaesthesia

You may qualify if:

  • 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

You may not qualify if:

  • Participation in a clinical trial
  • Treatment with acetylsalicylic acid for cardiovascular indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin (there may be other sites in this country)

Berlin, Germany

Location

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

February 23, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations

DE(1)