Venous ThromboembolismDaPaRNCT05536791
A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
An observational study of Venous Thromboembolism, run by Boehringer Ingelheim at 6 sites in 4 countries.
Trial summary
The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Dabigatran Etexilate (DE)
- How many people
- 0 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 24 Nov 2022to 1 Oct 2024
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Paediatric patients from birth to < 2 years of age considered by investigator after screening as eligible for Dabigatran Etexilate (DE) treatment of acute Venous thromboembolism (VTE) or secondary prevention of recurrent VTE will be enrolled in the Post-Authorization Safety Study (PASS).
Who may be able to join
- Written informed consent from parents/care givers
- Children from birth to less than 2 years of age
- Initiation of Dabigatran Etexilate (DE) administration:
- for treatment of Venous thromboembolism (VTE) or/and
- prevention of recurrent VTE due to presence of unresolved clinical VTE risk factor(s).
Who cannot join
- Participation in any Randomised Clinical Trial or use of any investigational product
- Any contraindications to DE according to the EU Summary of Product Characteristics (SmPC)
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Netherlands2 sites
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GL
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Spain2 sites
Hospital Sant Joan de Déu
Barcelona, 08950
Hospital Materno Infantil Gregorio Marañón
Madrid, 28009
About this study
Official title: Safety of Dabigatran Etexilate (DE) for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Paediatric Patients From Birth to Less Than 2 Years of Age: a Prospective European Non-interventional Cohort Study Based on New Data Collection
The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.
The non-interventional study will be conducted in paediatric hospitals or paediatric departments of EEA member states where Venous thromboembolism (VTE) patients of the evaluated age group are treated.
- Conditions
- Venous Thromboembolism
- Being tested
- Dabigatran Etexilate (DE)
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran Etexilate (DE)Drug
Also called Pradaxa®
Dabigatran Etexilate (DE)
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients eligible for Dabigatran Etexilate (DE) VTE treatment and secondary VTE prevention | Not described Receives: Drug: Dabigatran Etexilate (DE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non-Major Bleeding Events (Non-MBE)
Major bleeding defined as:
- Fatal Bleeding,
- Clinically overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL (20 g/L) in a 24-hour period,
- Bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the central nervous system,
- Bleeding that requires surgical intervention in an operating suite.
Non-Major bleeding defined as:
- Any overt or macroscopic evidence of bleeding that does not fulfil the criteria for major bleeding. (Criteria for differentiation of Major Bleeding Events (MBEs) and Non-MBEs by the Perinatal and Paediatric Haemostasis Subcommittee of the Scientific and Standardization Committee (SSC) of the International Society on Thrombosis and Haemostasis (ISTH).)
Measured: up to 6 months
Secondary outcomes (2)
Incidence of Adverse Events (AEs)
Measured: up to 6 months
Incidence of Serious Adverse Events (SAEs)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start24 Nov 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Why it stopped: No patients were screened in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536791
- Sponsor's protocol ID
- 1160-0307
- Acronym
- DaPaR
- Status last verified
- Jun 2024
- First submitted
- 9 Sep 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Dabigatran Etexilate (DE) for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Paediatric Patients From Birth to Less Than 2 Years of Age: a Prospective European Non-interventional Cohort Study Based on New Data Collection
- ClinicalTrials.gov ID
- NCT05536791
- Acronym / sponsor ID
- DaPaR / 1160-0307
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients were screened in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 13 Sep 2022 (actual)
- 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 collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.
The non-interventional study will be conducted in paediatric hospitals or paediatric departments of EEA member states where Venous thromboembolism (VTE) patients of the evaluated age group are treated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients eligible for Dabigatran Etexilate (DE) VTE treatment and secondary VTE prevention | – | Drug: Dabigatran Etexilate (DE) |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Paediatric patients from birth to < 2 years of age considered by investigator after screening as eligible for Dabigatran Etexilate (DE) treatment of acute Venous thromboembolism (VTE) or secondary prevention of recurrent VTE will be enrolled in the Post-Authorization Safety Study (PASS).
Key inclusion criteria (5 listed)
- Written informed consent from parents/care givers
- Children from birth to less than 2 years of age
- Initiation of Dabigatran Etexilate (DE) administration:
Key exclusion criteria (2 listed)
- Participation in any Randomised Clinical Trial or use of any investigational product
- Any contraindications to DE according to the EU Summary of Product Characteristics (SmPC)
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 |
|---|---|---|
| Dabigatran Etexilate (DE)Also: Pradaxa®Dabigatran Etexilate (DE) | Drug | Pediatric patients eligible for Dabigatran Etexilate (DE) VTE treatment and secondary VTE prevention |
Primary outcome
Incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non-Major Bleeding Events (Non-MBE)
Time frame: up to 6 months
Major bleeding defined as: * Fatal Bleeding, * Clinically overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL (20 g/L) in a 24-hour period, * Bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the central nervous system, * Bleeding that requires surgical intervention in an operating suite. Non-Major bleeding defined as: - Any overt or macroscopic evidence of bleeding that does not fulfil the criteria for major bleeding. (Criteria for differentiation of Major Bleeding Events (MBEs) and Non-MBEs by the Perinatal and Paediatric Haemostasis Subcommittee of the Scientific and Standardization Committee (SSC) of the International Society on Thrombosis and Haemostasis (ISTH).)
2 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: up to 6 months
Incidence of Serious Adverse Events (SAEs)
Time frame: up to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Boehringer Ingelheim at 6 sites in 4 countries.
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 5 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: withdrawn, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, Spain, Germany, Sweden. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non-Major Bleeding Events (Non-MBE) (time frame: up to 6 months). 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 26 Jun 2024.