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

Platelet Dysfunction Clinical Trial

— RAPID  

Official title:

Documentation of the Efficacy of Desmopressin (MINIRIN Parenteral 4 Microgram/ml Solution for Injection) Within the Context of Surgical Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368730
• Other study ID #: 000149
• Status: Completed
• Phase: N/A
• First received: February 16, 2015
• Last updated: June 1, 2017
• Start date: June 2015
• Est. completion date: July 2016

Study information

• Verified date: June 2017
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Platelet Dysfunction

Intervention

Drug:
• desmopressin

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin (there may be other sites in this country)	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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