Respiration, ArtificialPhase 4NCT00196469
Impact of Heparin on the Need for Mechanical Ventilation in Neonates
A Phase 4 study testing heparin in people with Respiration, Artificial and Hemorrhage, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Respiration, Artificial, Hemorrhage
- What is being tested?
- heparin
- How many people
- 270 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2003to Mar 2007
- Phase
- Phase 4
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns < day 28 of life
- Necessity for intensive care treatment
- Necessity for parenteral drug or fluid application for at least five days
- Informed consent of parents
Who cannot join
- Body weight < 500g
- Mechanical ventilation directly after birth
- Major malformations
- Absolute indication for heparin
- Inborn hemorrhagic disease (e.g. hemophilia, von Willebrand disease)
- Cerebral bleeding or other major bleeding
- Platelet count < 50,000/µl
Trial locations and contacts
1 site in 1 country.
Andreas Greinacher, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine
Greifswald, 17487
Andreas Greinacher, MD, +49 3834-865482, greinach@uni-greifswald.de
Christoph Fusch, MD, +49-3834-866420, fusch@uni-greifswald.de
About this study
Official title: Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation
This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.
Read the detailed description
Title: Randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation
Primary endpoint: Percentage of neonates requiring mechanical ventilation in both groups
Secondary endpoints: Duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies
- Conditions
- Respiration, Artificial, Hemorrhage
- Being tested
- heparin
- Medical subject headings
- Respiratory Aspiration, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of neonates requiring mechanical ventilation
Secondary outcomes (4)
duration of dependency on mechanical ventilation
major bleeding
heparin induced thrombocytopenia
anti PF4/heparin antibodies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2003
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Greinacher, MD, Study chair, Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University GreifswaldChristoph Fusch, MD, Study director, Pediatric Department, Ernst-Moritz-Arndt-University GreifswaldAnne F Klenner, MD, Principal investigator, Medical Faculty, Ernst-Moritz-Arndt University Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196469
- Sponsor's protocol ID
- EMAU16253.00.00
- Status last verified
- Sep 2006
- First submitted
- 12 Sep 2005
- Last updated
- 23 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation
- ClinicalTrials.gov ID
- NCT00196469
- Acronym / sponsor ID
- EMAU16253.00.00
- Conditions
- Respiration, Artificial, Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Mar 2007
- First posted
- 20 Sep 2005 (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.
This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.
Detailed description
Title: Randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation
Primary endpoint: Percentage of neonates requiring mechanical ventilation in both groups
Secondary endpoints: Duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborns < day 28 of life
- Necessity for intensive care treatment
- Necessity for parenteral drug or fluid application for at least five days
- Informed consent of parents
Key exclusion criteria (7 listed)
- Body weight < 500g
- Mechanical ventilation directly after birth
- Major malformations
- Absolute indication for heparin
- Inborn hemorrhagic disease (e.g. hemophilia, von Willebrand disease)
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 |
|---|---|---|
| heparin | Drug | – |
Primary outcome
percentage of neonates requiring mechanical ventilation
4 secondary outcomes
duration of dependency on mechanical ventilation
major bleeding
heparin induced thrombocytopenia
anti PF4/heparin antibodies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2007.
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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.
Andreas Greinacher, MD contact
Andreas Greinacher, MD study chair
Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald
Christoph Fusch, MD study director
Pediatric Department, Ernst-Moritz-Arndt-University Greifswald
Anne F Klenner, MD principal investigator
Medical Faculty, Ernst-Moritz-Arndt University Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing heparin in people with Respiration, Artificial and Hemorrhage, run by University Medicine Greifswald 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Oct 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Greinacher, MD (greinach@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of neonates requiring mechanical ventilation. 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 23 Oct 2007.