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.

A placebo-controlled double blind, randomised feasibility trial of Desmopressin (DDAVP) in critical illness prior to procedures. - DRIVE - Desmopressin for procedures or Radiological InterVEntions

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001126-33-GB

Enrollment

Registered

2016-09-19

Start date

2016-11-29

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: OCTIM Injection Product Name: OCTIM Injection Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Desmopressin acetate

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: This is a feasibility trial, to evaluate whether it is feasible to administer desmopressin (or placebo) prior to an interventional procedure, in order to reduce the patient's risk of bleeding. The primary outcome will measure the proportion of eligible patients who are randomised into trial and receive the IMP.; Secondary Objective: Although this trial is primarily looking at feasibility (testing whether it is feasible to administer desmopressin in this setting), we will also look at several measures of efficacy. These include laboratory tests to check platelet function, bleeding events and the need for blood products (red cells, platelets) after the procedure. ;Primary end point(s): The primary outcome is the proportion of eligible patients who are randomised into trial and receive the IMP - this will determine whether it is feasible to administer desmopressin to patients in this setting. ;Timepoint(s) of evaluation of this end point: 40 patients randomised into the trial.	—

Measure

Time frame

Main Objective: This is a feasibility trial, to evaluate whether it is feasible to administer desmopressin (or placebo) prior to an interventional procedure, in order to reduce the patient's risk of bleeding. The primary outcome will measure the proportion of eligible patients who are randomised into trial and receive the IMP.; Secondary Objective: Although this trial is primarily looking at feasibility (testing whether it is feasible to administer desmopressin in this setting), we will also look at several measures of efficacy. These include laboratory tests to check platelet function, bleeding events and the need for blood products (red cells, platelets) after the procedure. ;Primary end point(s): The primary outcome is the proportion of eligible patients who are randomised into trial and receive the IMP - this will determine whether it is feasible to administer desmopressin to patients in this setting. ;Timepoint(s) of evaluation of this end point: 40 patients randomised into the trial.

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Countries

United Kingdom

Contacts

Public ContactMiss Emma Laing

NHS Blood and Transplant Clinical Trials Unit

emma.laing@nhsbt.nhs.uk01223588091

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026