Immature PlateletsiPLATELETNCT02361294
Immature Plateletes in the Etiopathology of Deep Venous Thrombosis
An observational study of Immature Platelets and Deep Venous Thrombosis, run by Technical University of Munich at 1 site in Germany.
Trial summary
The study is designed to evaluate the role of platelets and immature platelets in the ethiopathology of deep venous thrombosis and pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immature Platelets, Deep Venous Thrombosis
- What is being tested?
- Blood samples
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Jul 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: all-comers
Who may be able to join
- Patients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation.
- Control: Patients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography.
Who cannot join
- therapy with glycoprotein IIb/IIIa-antagonists within the last 10 days
- therapy with antiplatelet drugs (ASA, Clopidogrel, Ticagrelor, Prasugrel, Dipyridamol)
- preexisting anticoagulation
- number of platelets < 100.000/µl
- anemia (hematocrit < 35%, Hb < 10 g/dl)
- age > 80 y or < 18 y
Show all 22Show fewer
- renal insufficiency GFR < 30 ml/min
- hepatic impairment with an increased risk for bleeding or coagulopathy, or liver cirrhosis (≥ Child Pugh B)
- intracranial or intracerebral bleeding within the last six months
- intraspinal or intracerebral vascular anomalies
- clinically relevant acute bleedings
- malign disease
- infections within the last 7 d
- hematological, rheumatologic and autoimmune diseases
- operations within the last six months
- transfusion of rec celll concentrates within the last six months
- transfusion of fresh frozen plasma or platelet concentrates within the last month
- preexisting medication with CYP 3A4 inhibitors and inductors, p-glycoprotein inhibitors (Azol-Antimycotis, HIV protease-inhibitors)
- hypersensitivity/contraindications for Rivaroxaban
- pregnancy or lactation
- thrombophilia
- thrombocytopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study to Generate Hypotheses About the Role of Platelets and Immature Platelets in the Pathogenesis of Idiopathic Venous Thromboses and Pulmonary Embolisms
The study is designed to evaluate the role of platelets and immature platelets in the ethiopathology of deep venous thrombosis and pulmonary embolism.
- Conditions
- Immature Platelets, Deep Venous Thrombosis
- Being tested
- Blood samples
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation. Three blood samples are taken during the study period. A thrombophilia screening is carried out. Receives: Other: Blood samples | |
| Control | Patients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography. One to two blood samples are taken during the study period. Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
Measured: at time of diagnosis
Secondary outcomes (2)
Significantly higher values of platelet function in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
Measured: at time of diagnosis
A persistently increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the controls three months after diagnosis.
Measured: 3 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startDec 2014
- Primary completion7 Apr 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immature PlateletsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tareq Ibrahim, MD, Principal investigator, Senior consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361294
- Sponsor's protocol ID
- TechnischeUM 1
- Acronym
- iPLATELET
- Status last verified
- Aug 2018
- First submitted
- 6 Feb 2015
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Generate Hypotheses About the Role of Platelets and Immature Platelets in the Pathogenesis of Idiopathic Venous Thromboses and Pulmonary Embolisms
- ClinicalTrials.gov ID
- NCT02361294
- Acronym / sponsor ID
- iPLATELET / TechnischeUM 1
- Conditions
- Immature Platelets, Deep Venous Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 11 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.
The study is designed to evaluate the role of platelets and immature platelets in the ethiopathology of deep venous thrombosis and pulmonary embolism.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Blood samplesPatients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation. Three blood samples are taken during the study period. A thrombophilia screening is carried out. |
| Control | – | Other: Blood samplesPatients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography. One to two blood samples are taken during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all-comers
Key inclusion criteria (2 listed)
- Patients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation.
- Control: Patients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography.
Key exclusion criteria (22 listed)
- therapy with glycoprotein IIb/IIIa-antagonists within the last 10 days
- therapy with antiplatelet drugs (ASA, Clopidogrel, Ticagrelor, Prasugrel, Dipyridamol)
- preexisting anticoagulation
- number of platelets < 100.000/µl
- anemia (hematocrit < 35%, Hb < 10 g/dl)
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 |
|---|---|---|
| Blood samples | Other | Control, Patient |
Primary outcome
Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
Time frame: at time of diagnosis
2 secondary outcomes
Significantly higher values of platelet function in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
Time frame: at time of diagnosis
A persistently increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the controls three months after diagnosis.
Time frame: 3 months after diagnosis
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 13 Aug 2018.
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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.
Tareq Ibrahim, MD principal investigator
Senior consultant
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 Immature Platelets and Deep Venous Thrombosis, run by Technical University of Munich 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 2 inclusion and 22 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 13 Aug 2018. 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?
Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control. (time frame: at time of diagnosis). 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 13 Aug 2018.