Condition category
Haematological Disorders
Date applied
30/01/2017
Date assigned
30/01/2017
Last edited
31/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Platelets are the component of blood which helps the blood to clot. People with low platelet counts are vulnerable to bleeding. Approximately one third of patients in intensive care have a low platelet count and the majority undergo at least one invasive procedure during their time in intensive care. Desmopressin is a medication commonly used for congenital (from birth) bleeding disorders such as haemophilia and von Willebrand disease and it has few side effects. This study aims to assess the feasibility of administering desmopressin to these patients with low platelet counts before they undergo surgery.

Who can participate?
Adults with low platelet counts who are scheduled to have an interventional procedure (a procedure that involves making a cut in the body).

What does the study involve?
Participants are randomly allocated to receive a single dose through drip of either desmopressin or placebo (dummy drug), prior they have their interventional procedure. The surgery is conducted according to standard practice. Blood samples are collected before the treatment, and at 30 minutes and 120 minutes after treatment. Participant progress is checked after 24 hours, then at 7 days, and at 28 days after the treatment.

What are the possible benefits and risks of participating?
Administering desmopressin may prevent procedure-related serious bleeding events, but at present it is not known if this will be the case. It has proven to be effective at reducing bleeding for people who are undergoing surgery, but this trial will look at whether it will also work well for Intensive Care patients. Some patients may experience facial flushing (redness in the face), nausea (feeling sick) or stomach pain, or headache. Rarely people will get a low blood pressure during the infusion of desmopressin. Some people may develop low levels of salt (sodium) in their blood after they receive desmopressin. Very rarely (in less than 1 in 10,000 people) desmopressin may cause very low salt levels which can lead to seizures. Very rarely desmopressin could cause an allergic reaction. Participants will be closely monitored for any evidence of these side-effects.

Where is the study run from?
NHS Blood and Transplant Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for?
January 2016 to December 2018

Who is funding the study?
NHS Blood and Transplant (UK)

Who is the main contact?
Miss Emma Laing
emma.laing@nhsbt.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Miss Emma Laing

ORCID ID

http://orcid.org/0000-0002-8309-0990

Contact details

NHS Blood and Transplant
Clinical Trials Unit
Long Road
Cambridge
CB2 0PT
United Kingdom
+44 1223 588091
emma.laing@nhsbt.nhs.uk

Additional identifiers

EudraCT number

2016-001126-33

ClinicalTrials.gov number

Protocol/serial number

32526

Study information

Scientific title

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

Acronym

DRIVE

Study hypothesis

The aim of this study is to investigate the feasibility of administering desmopressin in intensive care.

Ethics approval

South Central - Oxford C Research Ethics Committee, 29/11/2016, ref: 16/SC/0524

Study design

Randomised; Interventional; Design type: Treatment, Prevention, Drug

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Specialty: Critical care, Primary sub-specialty: Critical Care; UKCRC code/ Disease: Blood/ Other diseases of blood and blood-forming organs

Intervention

Following provision of informed consent, participants will be randomised to receive a single intravenous infusion of either desmopressin (0.3 micrograms per kg, made up to 50mL with saline) or placebo (50mL saline). All participants will be followed-up until Day 28 post-treatment.

Intervention type

Drug

Phase

Drug names

Demopressin

Primary outcome measures

Proportion of eligible patients who are randomised and receive the IMP is assessed by analysis of screening and recruitment data at the end of the study.

Secondary outcome measures

1. Adherence to protocol measured at 28 days post-treatment, measured by analysis of Case Report Forms at the end of the study
2. Time taken to administer IMP (from randomisation), measured by analysis of Case Report Forms at the end of the study
3. Difference in change in percentage aggregation of platelets in microfluidics chamber between desmopressin and placebo before and after IMP, measured by blood tests at pre-treatment, 30 minutes post-treatment and 120 minutes post-treatment
4. Difference in change in PFA-200 closure time for ADP/collagen and P2Y cartridges between desmopressin and placebo before and after IMP, measured by blood tests at pre-treatment, 30 minutes post-treatment and 120 minutes post-treatment
5. Difference in change in thrombin generation, between desmopressin and placebo before and after IMP, measured by blood tests at pre-treatment, 30 minutes post-treatment and 120 minutes post-treatment
6. Bleeding up to 24 hours after administration of IMP, measured using the HEME (Haemorrhage Measurement Tool) Bleeding Assessment at 24 hours
7. Thromboembolic events up to 28 days after administration of IMP, measured by reviewing patient notes at Day 1, Day 7 and Day 28.
8. Exposure to blood products (red cell transfusion, platelet transfusion) up to 24 hours after administration of IMP, measured by reviewing patient notes at Day 1

Overall trial start date

01/01/2016

Overall trial end date

31/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Platelet count less than or equal to 100 x 10^9/L
3. Inpatient on a critical care ward
4. Due to undergo an invasive procedure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

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

Recruitment start date

31/01/2017

Recruitment end date

30/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Blood and Transplant Clinical Trials Unit
Long Road
Cambridge
CB2 0PT
United Kingdom

Sponsor information

Organisation

NHS Blood and Transplant

Sponsor details

500 North Bristol Park
Filton
Bristol
BS34 7QH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NHS Blood and Transplant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan to publish the study results in a peer-reviewed journal, as soon as possible following database lock.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes