Acute Respiratory FailureNCT02966080
Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous ECMO With a Heparin Bonded Circuit.
A study testing HEP-IV in people with Acute Respiratory Failure and Extracorporeal Membrane Oxygenation Complication, run by University of Arizona at 1 site in United States.
Trial summary
Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials used in ECMO machines may help prevent clots - this could allow the use of lower doses of heparin which might reduce the risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Extracorporeal Membrane Oxygenation Complication, Bleeding
- What is being tested?
- HEP-IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Feb 2021
- Phase
- Interventional
- 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
Who may be able to join
- on ECMO for acute respiratory failure, achieving ECMO blood flow rate >3L/min,
- patient or surrogate able to speak/understand English or Spanish
Who cannot join
- History of heparin-induced thrombocytopenia, decision by clinicians to run ECMO off heparin due to high bleeding risk,
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
Official title: Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous Extracorporeal Membrane Oxygenation (ECMO) With a Heparin Bonded Circuit.
Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials used in ECMO machines may help prevent clots - this could allow the use of lower doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent clotting, but may cause less bleeding and be safer for patients.
Read the detailed description
Intravenous heparin is considered standard therapy to prevent clotting complications in patients on ECMO, however the optimal method of heparin dosing has not yet been determined. International surveys have shown that most ECMO centers use adjusted dose heparin to achieve an activated clotting time of at least 180 seconds. However, heparin may contribute to the most common complication of ECMO - bleeding. Advances in material technology have potentially reduced the thrombogenicity of modern ECMO circuits. Our observational data suggest that fixed low dose heparin infusion may reduce the rate of bleeding complications from 75% to 50% compared to standard adjusted-dose heparin, without increasing clotting complications. We intend to perform a randomized controlled trial in adults receiving venovenous ECMO comparing these two heparin regimens. The main outcome measures are bleeding complications and oxygenator failure due to clotting. A safety committee will monitor the results of the study. Power calculations indicate a sample size of 110 patients is required, which we estimate will take us five years to achieve.
- Being tested
- HEP-IV
- Keywords
- extracorporeal membrane oxygenation, intravenous heparin
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEP-IVDrug
Also called heparin
| Study group | Role | What they receive |
|---|---|---|
| Adjusted-dose heparin | Other | Patients in this arm of the study will receive intravenous unfractionated heparin at a dose adjusted to achieve an activated clotting time of 180-200 seconds. Receives: Drug: HEP-IV |
| Fixed low-dose heparin | Other | Patients in this arm of the study will receive intravenous unfractionated heparin at 500 units/hour without activated clotting time monitoring. Receives: Drug: HEP-IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
significant bleeding complications
requires surgery, >1 unit packed blood cell transfusion or is intracranial, pulmonary or retroperitoneal
Measured: intraoperative
Secondary outcomes (2)
Oxygenator failure
Requirement to replace oxygenator due to clotting
Measured: intraoperative
cerebral vascular event (stroke)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: No participants enrolled, study will not be conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Raschke, University of Arizona
- Investigators
- Robert Raschke, MD, Principal investigator, Banner University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966080
- Sponsor's protocol ID
- 1609884386
- Status last verified
- Aug 2017
- First submitted
- 15 Nov 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Esper SA, Levy JH, Waters JH, Welsby IJ. Extracorporeal membrane oxygenation in the adult: a review of anticoagulation monitoring and transfusion. Anesth Analg. 2014 Apr;118(4):731-43. doi: 10.1213/ANE.0000000000000115.
PubMed 24651227Poulos EM, Raschke R, Amabile O et al. A Nonrandomized comparison of three different heparin infusion strategies for patients receiving venovenous extracorporeal membrane oxygenation. Am J Respir Crit Care Med 2014;189: A4499.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous Extracorporeal Membrane Oxygenation (ECMO) With a Heparin Bonded Circuit.
- ClinicalTrials.gov ID
- NCT02966080
- Acronym / sponsor ID
- 1609884386
- Keywords
- extracorporeal membrane oxygenation, intravenous heparin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled, study will not be conducted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 17 Nov 2016 (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.
Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials used in ECMO machines may help prevent clots - this could allow the use of lower doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent clotting, but may cause less bleeding and be safer for patients.
Detailed description
Intravenous heparin is considered standard therapy to prevent clotting complications in patients on ECMO, however the optimal method of heparin dosing has not yet been determined. International surveys have shown that most ECMO centers use adjusted dose heparin to achieve an activated clotting time of at least 180 seconds. However, heparin may contribute to the most common complication of ECMO - bleeding. Advances in material technology have potentially reduced the thrombogenicity of modern ECMO circuits. Our observational data suggest that fixed low dose heparin infusion may reduce the rate of bleeding complications from 75% to 50% compared to standard adjusted-dose heparin, without increasing clotting complications. We intend to perform a randomized controlled trial in adults receiving venovenous ECMO comparing these two heparin regimens. The main outcome measures are bleeding complications and oxygenator failure due to clotting. A safety committee will monitor the results of the study. Power calculations indicate a sample size of 110 patients is required, which we estimate will take us five years to achieve.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjusted-dose heparin | Other | Drug: HEP-IVPatients in this arm of the study will receive intravenous unfractionated heparin at a dose adjusted to achieve an activated clotting time of 180-200 seconds. |
| Fixed low-dose heparin | Other | Drug: HEP-IVPatients in this arm of the study will receive intravenous unfractionated heparin at 500 units/hour without activated clotting time monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- on ECMO for acute respiratory failure, achieving ECMO blood flow rate >3L/min,
- patient or surrogate able to speak/understand English or Spanish
Key exclusion criteria (2 listed)
- History of heparin-induced thrombocytopenia, decision by clinicians to run ECMO off heparin due to high bleeding risk,
- pregnancy
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 |
|---|---|---|
| HEP-IVAlso: heparin | Drug | Adjusted-dose heparin, Fixed low-dose heparin |
Primary outcome
significant bleeding complications
Time frame: intraoperative
requires surgery, >1 unit packed blood cell transfusion or is intracranial, pulmonary or retroperitoneal
2 secondary outcomes
Oxygenator failure
Time frame: intraoperative
cerebral vascular event (stroke)
Time frame: intraoperative
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 21 Aug 2017.
- Background: PubMed 24651227Esper SA, Levy JH, Waters JH, Welsby IJ. Extracorporeal membrane oxygenation in the adult: a review of anticoagulation monitoring and transfusion. Anesth Analg. 2014 Apr;118(4):731-43. doi: 10.1213/ANE.0000000000000115.
- BackgroundPoulos EM, Raschke R, Amabile O et al. A Nonrandomized comparison of three different heparin infusion strategies for patients receiving venovenous extracorporeal membrane oxygenation. Am J Respir Crit Care Med 2014;189: A4499.
- ELSO anticoagulation guidelineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Robert Raschke, MD principal investigator
Banner University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEP-IV in people with Acute Respiratory Failure and Extracorporeal Membrane Oxygenation Complication, run by University of Arizona at 1 site in United States.
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 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 21 Aug 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 United States. 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?
significant bleeding complications (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02966080, which also lists 2 linked publications.
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 21 Aug 2017.