DRIVE - Desmopressin for procedures or radiological interventions
| ISRCTN | ISRCTN12845429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12845429 |
| EudraCT/CTIS number | 2016-001126-33 |
| Secondary identifying numbers | CPMS 32526 |
- Submission date
- 30/01/2017
- Registration date
- 30/01/2017
- Last edited
- 05/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
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 July 2019
Who is funding the study?
NHS Blood and Transplant (UK)
Who is the main contact?
Miss Emma Laing
emma.laing@nhsbt.nhs.uk
Contact information
Public
NHS Blood and Transplant
Clinical Trials Unit
Long Road
Cambridge
CB2 0PT
United Kingdom
 ORCID ID |
0000-0002-8309-0990 |
|---|---|
| Phone | +44 1223 588091 |
| emma.laing@nhsbt.nhs.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Prevention, Drug |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | A placebo-controlled double-blind, randomised feasibility trial of Desmopressin (DDAVP) in critical illness prior to procedures |
| Study acronym | DRIVE |
| Study hypothesis | The aim of this study is to investigate the feasibility of administering desmopressin in intensive care. |
| Ethics approval(s) | South Central - Oxford C Research Ethics Committee, 29/11/2016, ref: 16/SC/0524 |
| Condition | Low platelet count |
| Intervention | Following the 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 50 ml with saline) or placebo (50 ml saline). All participants will be followed up until Day 28 post-treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Desmopressin |
| Primary outcome measure | 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 study start date | 01/01/2016 |
| Overall study end date | 04/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Total final enrolment | 40 |
| 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 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 | 06/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cambridge
CB2 0PT
United Kingdom
Sponsor information
Hospital/treatment centre
500 North Bristol Park
Filton
Bristol
BS34 7QH
England
United Kingdom
"ROR" |
https://ror.org/0227qpa16 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 04/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 04/10/2021 | 06/10/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 16/06/2024 | 05/02/2025 | Yes | No |
Additional files
Editorial Notes
05/02/2025: Publication reference added.
06/10/2021: The basic results have been uploaded as an additional file.
04/07/2019: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/06/2019 to 04/07/2019.
2. The intention to publish date was changed from 30/06/2020 to 04/07/2020.
17/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2019 to 06/06/2019.
2. The total final enrolment was added.
14/06/2019: The recruitment end date was changed from 30/05/2019 to 30/06/2019.
28/03/2019: The condition has been changed from "Specialty: Critical care, Primary sub-specialty: Critical Care; UKCRC code/ Disease: Blood/ Other diseases of blood and blood-forming organs" to "Low platelet count" following a request from the NIHR.
LM 03/08/2018: The following changes have been made to the trial record:
1. The overall trial end date was changed from 31/01/2019 to 30/06/2019
2. The recruitment end date was changed from 30/04/2018 to 30/05/2019
3. The intention to publish date was changed from 31/12/2017 to 30/06/2020
