Platelet DysfunctionRAPIDNCT02368730
Documentation of the Efficacy of Desmopressin Within the Context of Surgical Procedures
An observational study of Platelet Dysfunction, run by Ferring Pharmaceuticals at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Dysfunction
- What is being tested?
- desmopressin
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital doctors specialised in anaesthesia
Who may be able to join
- 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
Who cannot join
- Participation in a clinical trial
- Treatment with acetylsalicylic acid for cardiovascular indications
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin (there may be other sites in this country)
Berlin
About this study
Official title: Documentation of the Efficacy of Desmopressin (MINIRIN Parenteral 4 Microgram/ml Solution for Injection) Within the Context of Surgical Procedures
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.
- Conditions
- Platelet Dysfunction
- Being tested
- desmopressin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desmopressinDrug
Also called Minirin
| Study group | Role | What they receive |
|---|---|---|
| desmopressin | Treatment according to standard clinical practice. Receives: Drug: desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in platelet function pre- and post-administration of desmopressin
As measured by Platelet Function Analyzer (PFA) 100/200
Measured: From baseline up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368730
- Sponsor's protocol ID
- 000149
- Acronym
- RAPID
- Status last verified
- Jun 2017
- First submitted
- 16 Feb 2015
- Last updated
- 2 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of the Efficacy of Desmopressin (MINIRIN Parenteral 4 Microgram/ml Solution for Injection) Within the Context of Surgical Procedures
- ClinicalTrials.gov ID
- NCT02368730
- Acronym / sponsor ID
- RAPID / 000149
- Conditions
- Platelet Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| desmopressin | – | Drug: desmopressinTreatment according to standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital doctors specialised in anaesthesia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in a clinical trial
- Treatment with acetylsalicylic acid for cardiovascular indications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desmopressinAlso: Minirin | Drug | desmopressin |
Primary outcome
Change in platelet function pre- and post-administration of desmopressin
Time frame: From baseline up to 7 days
As measured by Platelet Function Analyzer (PFA) 100/200
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Dysfunction, run by Ferring Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in platelet function pre- and post-administration of desmopressin (time frame: From baseline up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.