Heparin-induced ThrombocytopeniaTIH ECMONCT03979625
Prognosis Related to Induced Thrombopenia With Heparin Under Venoarterial ECMO in Reanimation
An observational study of Heparin-induced Thrombocytopenia, run by Central Hospital, Nancy, France.
Trial summary
Thrombocytopenia is a frequent and serious adverse event in patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for refractory cardiogenic shock. Similarly to postcardiac surgery patients, heparin-induced thrombocytopenia (HIT) could represent the causative underlying mechanism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-induced Thrombocytopenia
- What is being tested?
- Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodies
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Apr 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in intensive care for cardiogenic shock requiring cardiac assisting with ECMO-VA.
Who may be able to join
- Age ≥ 18 years
- Patient hospitalized in intensive care for a cardiovascular failure requiring the setting up of an ECMO-VA
- ECMO-VA duration ≥ 3 days
- HIT confirmed by immunological tests
- Patient affiliated to a Social Security scheme
Who cannot join
- Known antecedent of TIH prior to cannulation
- Pregnant woman
- ECMO-VA following cardiopulmonary arrest or septic shock
About this study
Thrombocytopenia is a frequent and serious adverse event in patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for refractory cardiogenic shock. Similarly to postcardiac surgery patients, heparin-induced thrombocytopenia (HIT) could represent the causative underlying mechanism. However, the epidemiology as well as related mortality regarding HIT and VA-ECMO remains largely unknown. The investigators aimed to define the prevalence and associated 90-day mortality of HIT diagnosed under VA-ECMO.This retrospective study included patients under VA-ECMO from 20 French centers between 2012 and 2016.
- Conditions
- Heparin-induced Thrombocytopenia
- Being tested
- Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodiesOther
Patients are classified according to results of functional tests as having either Confirmed or Excluded HIT.
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 90 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Jan 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heparin-induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979625
- Sponsor's protocol ID
- PSS 2016/TIH ECMO-KIMMOUN/SR
- Acronym
- TIH ECMO
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Related to Induced Thrombopenia With Heparin Under Venoarterial ECMO in Reanimation
- ClinicalTrials.gov ID
- NCT03979625
- Acronym / sponsor ID
- TIH ECMO / PSS 2016/TIH ECMO-KIMMOUN/SR
- Conditions
- Heparin-induced Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 7 Jun 2019 (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.
Thrombocytopenia is a frequent and serious adverse event in patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for refractory cardiogenic shock. Similarly to postcardiac surgery patients, heparin-induced thrombocytopenia (HIT) could represent the causative underlying mechanism. However, the epidemiology as well as related mortality regarding HIT and VA-ECMO remains largely unknown. The investigators aimed to define the prevalence and associated 90-day mortality of HIT diagnosed under VA-ECMO.This retrospective study included patients under VA-ECMO from 20 French centers between 2012 and 2016.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in intensive care for cardiogenic shock requiring cardiac assisting with ECMO-VA.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patient hospitalized in intensive care for a cardiovascular failure requiring the setting up of an ECMO-VA
- ECMO-VA duration ≥ 3 days
- HIT confirmed by immunological tests
- Patient affiliated to a Social Security scheme
Key exclusion criteria (3 listed)
- Known antecedent of TIH prior to cannulation
- Pregnant woman
- ECMO-VA following cardiopulmonary arrest or septic shock
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 |
|---|---|---|
| Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodiesPatients are classified according to results of functional tests as having either Confirmed or Excluded HIT. | Other | – |
Primary outcome
Death
Time frame: 90 days after inclusion
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 7 Jun 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heparin-induced Thrombocytopenia, run by Central Hospital, Nancy, France.
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 3 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 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Death (time frame: 90 days after inclusion). 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 7 Jun 2019.