A randomised controlled trial to evaluate the feasibility of administering a drug called desmopressin to Intensive Care patients prior to procedures or radiological interventions, for prophylaxis against bleeding.

Phase 1

• Conditions: Thrombocytopenic patients (platelet count less than or equal to 100x109/L) in Intensive Care and due to undergo an interventional procedure.; MedDRA version: 19.0 Level: PT Classification code 10036898 Term: Prophylaxis System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-001126-33-GB
• Lead Sponsor: HS Blood and Transplant

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-19
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

•Adult patients (age 18 years or above)
•Platelet count =100 x 109/L
•Inpatient on a critical care ward
•Due to undergo an interventional procedure
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Active bleeding
•History of ischaemic heart disease (myocardial infarction or angina), stroke or transient ichaemic attack (TIA)
•Admission to ICU with traumatic brain injury or seizures
•Congenital bleeding disorder
•Pregnant or breastfeeding
•History of anaphylaxis to desmopressin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified