Antithrombin Deficiency Type 2Early Phase 1NCT03090893
Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients
A Early Phase 1 study testing ATryn continuous infusion in people with Antithrombin Deficiency Type 2, run by Mayo Clinic.
Trial summary
The objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Antithrombin Deficiency Type 2
- What is being tested?
- ATryn continuous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to Jun 2019
- Phase
- Early Phase 1
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completed cardiac surgery with Cardiopulmonary Bypass and subsequently placed on venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO) support at any point during the ongoing hospitalization
- Serum Antithrombin < 60%.
Who cannot join
- Heart transplantation during ongoing hospitalization
- Excessive bleeding (300 ml/hr of chest tube drainage for 2 consecutive hours)
- Weight < 40 kg
- Allergy to goat products
- Anticoagulation with a direct thrombin inhibitor
- Religious exception to blood products
- Hypothermia (< 34°C)
About this study
Official title: A Pilot Study, Prospective, Non-Randomized, Non-Blinded, Single-Center Study Evaluating the Response of Continuous Recombinant Antithrombin (ATryn) Infusion in Postcardiotomy ECMO Patients
The objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac surgery.
- Conditions
- Antithrombin Deficiency Type 2
- Being tested
- ATryn continuous infusion
- Medical subject headings
- Antithrombin deficiency type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATryn continuous infusionDrug
replenish serum thrombin levels
| Study group | Role | What they receive |
|---|---|---|
| Infusion group | Experimental | Subjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100 Receives: Drug: ATryn continuous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time within the serum AT level target range of 80-100%
Target value of Antithrombin is recorded as %
Measured: 72 hour infusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Jun 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: PI passed away
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antithrombin Deficiency Type 2Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- rEVO Biologics
- Responsible party
- Principal investigator, William C. Oliver, Mayo Clinic
- Investigators
- William C. Oliver, Jr., MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090893
- Sponsor's protocol ID
- 15-001713
- Status last verified
- Sep 2018
- First submitted
- 21 Mar 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: will not share individual patient data
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study, Prospective, Non-Randomized, Non-Blinded, Single-Center Study Evaluating the Response of Continuous Recombinant Antithrombin (ATryn) Infusion in Postcardiotomy ECMO Patients
- ClinicalTrials.gov ID
- NCT03090893
- Acronym / sponsor ID
- 15-001713
- Conditions
- Antithrombin Deficiency Type 2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI passed away
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- rEVO Biologics
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 27 Mar 2017 (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 objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infusion group | Experimental | Drug: ATryn continuous infusionSubjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completed cardiac surgery with Cardiopulmonary Bypass and subsequently placed on venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO) support at any point during the ongoing hospitalization
- Serum Antithrombin < 60%.
Key exclusion criteria (7 listed)
- Heart transplantation during ongoing hospitalization
- Excessive bleeding (300 ml/hr of chest tube drainage for 2 consecutive hours)
- Weight < 40 kg
- Allergy to goat products
- Anticoagulation with a direct thrombin inhibitor
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 |
|---|---|---|
| ATryn continuous infusionreplenish serum thrombin levels | Drug | Infusion group |
Primary outcome
Percentage of time within the serum AT level target range of 80-100%
Time frame: 72 hour infusion period
Target value of Antithrombin is recorded as %
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 10 Sep 2018.
- Individual participant dataSharing planned: No. will not share individual patient data
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.
William C. Oliver, Jr., MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ATryn continuous infusion in people with Antithrombin Deficiency Type 2, run by Mayo Clinic.
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 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: withdrawn, as of the sponsor's last update on 10 Sep 2018. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of time within the serum AT level target range of 80-100% (time frame: 72 hour infusion period). 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 10 Sep 2018.