Extracorporeal Membrane Oxygenation ComplicationPhase 1NCT02631174
Evaluation Of The Pharmacokinetics Of Antithrombin III In Neonates And Infants Undergoing CPB And ECMO Support
A Phase 1 study testing Antithrombin III in people with Extracorporeal Membrane Oxygenation Complication and Cardiopulmonary Bypass, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The potential role of ATIII in achieving and maintaining adequate anticoagulation in pediatric patients on the heart-lung machine has recently taken on increased importance as caregivers strive to mitigate the risk for clinically significant clotting problems. Read more about this study
- Who is it for?
- Ages Up to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Cardiopulmonary Bypass
- What is being tested?
- Antithrombin III
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2018
- Phase
- 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 Up to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Neonates less than or equal to 28 days of age OR Infants between 29 days and 1 year of age;
- 2. ATIII activity less than 80% at time of screening;
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Known or suspected bleeding disorder;
- Neonates with gestational age <36 weeks;
- Neonates with evidence of intracranial hemorrhage on routine cranial ultrasound;
- Documented infection (sepsis);
- Patients who require post-cardiotomy ECMO;
Show all 9Show fewer
- Patients who require E-CPR; and/or
- Neonates or infants deemed to be at increased risk as judged by the investigator or for whom administration of hpATIII is not in their best interest
- Additional Exclusion for Cohort 1 only: Transfusion of whole blood, fresh frozen plasma (FFP), platelets or cryoprecipitate prior to study;
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The potential role of ATIII in achieving and maintaining adequate anticoagulation in pediatric patients on the heart-lung machine has recently taken on increased importance as caregivers strive to mitigate the risk for clinically significant clotting problems. It is known that ATIII levels are decreased in normal neonates and infants less than 6 months of age relative to older children and adults and become even further decreased in critically ill neonates and infants, including those with congenital heart disease. The current utilization of ATIII in the context of support on a heart-lung machine is based on pharmacokinetic data derived from adult subjects with congenital ATIII deficiency. There is a gap in knowledge as to the appropriate frequency of ATIII repletion, best method of monitoring, and mode of administration in critically ill neonates and infants receiving support on a heart-lung machine.Our long-term goal is to determine if antithrombin (ATIII) can effectively change the coagulation system in patients undergoing heart-lung machine support. The objective of this proposal, which is our first step in pursuit of that goal, is to determine the pharmacokinetics of ATIII in neonates and infants. Our central hypothesis is that ATIII will have different pharmacokinetic properties in neonates and infants than adults and these properties will be affected by the use of heart-lung machine.
This research will result in critical data on the pharmacokinetics of ATIII in neonates and infants receiving heart-lung machine support. This contribution is significant because it is the first step in a continuum of research that is expected to lead to the development of a therapeutic strategy employing ATIII that will facilitate improved modulation of the coagulation cascade to prevent significant clotting and bleeding complications in pediatric patients requiring heart-lung machine support.
Read the detailed description
This is a single-site, prospective, open-label, pharmacokinetic study of hpATIII in neonates and infants. Patients admitted to the Cardiac Intensive Care Unit (CICU) and the Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC) will be enrolled. Participants will be enrolled into one of three cohorts depending on whether they are scheduled for ECMO, CPB, or neither, and based on age (neonate or infant).
Two doses of hpATIII will be used; one according to current labelling for hpATIII and one that accounts for the additional circuit volume from ECMO or CPB. Pharmacokinetic measurements will be obtained for all groups at baseline prior to administration of hpATIII and at multiple defined times up to 120 hrs following each administration of hpATIII.
Administration of hpATIII is standard of care at CCHMC for participants undergoing ECMO. The standard dose administered for clinical care is (120 - baseline AT activity level) x weight (kg) / 1.4. For participants not undergoing ECMO for clinical care, or for those undergoing ECMO but receiving an adjusted dose for additional circuit volume , the administration of hpATIII is considered research.
The duration of the study at CCHMC is expected to be 2.5 years. This includes 24 months for recruitment and data collection, and 6 months for data analysis and report writing.
Individual participants will be in the study for approximately 120 hours (5 days) following administration of hpATIII. If participants receive more than 1 dose, they will be in the study for approximately 120 hours following each dose of hpATIII received.
- Being tested
- Antithrombin III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin IIIDrug
We are comparing neonates and infants on ECMP or CPB receiving ATIII, the dose of which is calculated to account for circuit volume, and compared with those not accounting for circuit volume
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | No intervention | Cohort 1 (Aim 1) - 6 participants Cohort 1 will be comprised of 6 neonates (≤28 days of age) admitted to the CICU or NICU who are neither undergoing ECMO nor CPB. Cohort 1 will receive a single dose of ATIII by short 15 minute infusion. |
| cohort 2.1 | Active comparator | • Cohort 2.1 - 6 neonates undergoing ECMO.
* Three participants will receive a single dose 15 minute infusion of hpATIII that is dose adjusted to account for additional circuit volume followed by a single dose 15 minute infusion of ATIII that is not dose adjusted to account for circuit volume
* Three participants will receive a single dose 15 minute infusion of hpATIII that is not dose adjusted to account for circuit volume followed by a single dose 15 minute infusion of hpATIII that is dose adjusted to account for additional circuit volume Receives: Drug: Antithrombin III |
| cohort 2.2 | Active comparator | • Cohort 2.2 - 12 neonates who will undergo open-heart surgery with CPB
* Six participants will receive a single dose 15 minute infusion of ATIII that is dose adjusted to account for additional circuit volume.
* Six participants will receive a single dose 15 minute infusion of ATIII that is not dose adjusted to account for circuit volume Receives: Drug: Antithrombin III |
| cohort 2.3 | Active comparator | • Cohort 2.3 - 12 infants who will undergo open-heart surgery with CPB
* Six participants will receive a single dose 15 minute infusion of ATIII that is dose adjusted to account for additional circuit volume.
* Six participants will receive a single dose 15 minute infusion of ATIII that is not dose adjusted to account for circuit volume Receives: Drug: Antithrombin III |
| cohort 3 | Active comparator | Cohort 3 (Aim 3) - 6 participants Six participants (neonates or infants) who will undergo ECMO and receive ATIII as standard of care will be enrolled and have a baseline ATIII level measured within 6 hours of ATIII administration and repeated within 15 minutes of initiation of extracorporeal support. If post-support level is < 80% normal activity then an ATIII level will be repeated and participants will be assigned to one of two hpATIII dosing regimens in which one formula accounts for additional circuit volume and one formula does not account for additional circuit volume, as described in section 7.4. Upon completion and 120 hr follow up after the first dose, participants still having ATIII activity less than 80% will then receive a second dose Receives: Drug: Antithrombin III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1:To determine the pharmacokinetics of a single dose of hpATIII in neonates not undergoing ECMO or CPB.
Blood samples (0.5 mL) for analysis of plasma ATIII concentration will be drawn at specific time points, e.g. before and after the dose of ATIII is given ,together with coagulation labs such as prothrombin/ thrombin anti thrombin complex and CBC, PT/PTT/INR at baseline, 12 and 24 hrs only.If clinical labs exist, those will be used instead for that time point.
Measured: participants in cohort 1 will have sampling up to 36 hrs after receiving their single dose of ATIII
Aim 2:To determine the pharmacokinetics of a single dose of hpATIII in neonates and infants undergoing ECMO or CPB
Blood samples (0.5 mL) for analysis of plasma ATIII concentration will be drawn at specific time points, e.g.before and after the dose of ATIII is given,together with coagulation labs such as prothrombin/ thrombin anti thrombin complex and CBC, PT/PTT/INR at baseline, 12 and 24 hrs only. If clinical labs exist, those will be used instead for that time point.
Measured: participants will be followed for 120hrs after recieving their single dose of ATIII
Aim 3:To determine the pharmacokinetics of hpATIII administered by continuous infusion in neonates and infants undergoing ECMO
Blood samples (0.5 mL) for analysis of plasma ATIII concentration will be drawn at specific time points, e.g.before and after the dose of ATIII is given,together with coagulation labs such as prothrombin/ thrombin anti thrombin complex and CBC, PT/PTT/INR at baseline, 12 and 24 hrs only. If clinical labs exist, those will be used instead for that timepoint.
Measured: participants will be followed for a period of 120hrs after recieving half the dose as a bolus and the rest as a continuous infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Responsible party
- Sponsor
- Investigators
- David Cooper, MD, Principal investigator, Cincinnati Childrens Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631174
- Sponsor's protocol ID
- 2014-6716
- Status last verified
- Jan 2019
- First submitted
- 13 Nov 2015
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guzzetta NA, Bajaj T, Fazlollah T, Szlam F, Wilson E, Kaiser A, Tosone SR, Miller BE. A comparison of heparin management strategies in infants undergoing cardiopulmonary bypass. Anesth Analg. 2008 Feb;106(2):419-25, table of contents. doi: 10.1213/01.ane.0000297290.03501.db.
PubMed 18227295D'Argenio DZ. Optimal sampling times for pharmacokinetic experiments. J Pharmacokinet Biopharm. 1981 Dec;9(6):739-56. doi: 10.1007/BF01070904.
PubMed 7341758Esmon CT. The interactions between inflammation and coagulation. Br J Haematol. 2005 Nov;131(4):417-30. doi: 10.1111/j.1365-2141.2005.05753.x.
PubMed 16281932Avidan MS, Levy JH, van Aken H, Feneck RO, Latimer RD, Ott E, Martin E, Birnbaum DE, Bonfiglio LJ, Kajdasz DK, Despotis GJ. Recombinant human antithrombin III restores heparin responsiveness and decreases activation of coagulation in heparin-resistant patients during cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2005 Jul;130(1):107-13. doi: 10.1016/j.jtcvs.2004.10.045.
PubMed 15999048
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Pharmacokinetics Of Antithrombin III In Neonates And Infants Undergoing CPB And ECMO Support
- ClinicalTrials.gov ID
- NCT02631174
- Acronym / sponsor ID
- 2014-6716
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 16 Dec 2015 (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.
The potential role of ATIII in achieving and maintaining adequate anticoagulation in pediatric patients on the heart-lung machine has recently taken on increased importance as caregivers strive to mitigate the risk for clinically significant clotting problems. It is known that ATIII levels are decreased in normal neonates and infants less than 6 months of age relative to older children and adults and become even further decreased in critically ill neonates and infants, including those with congenital heart disease. The current utilization of ATIII in the context of support on a heart-lung machine is based on pharmacokinetic data derived from adult subjects with congenital ATIII deficiency. There is a gap in knowledge as to the appropriate frequency of ATIII repletion, best method of monitoring, and mode of administration in critically ill neonates and infants receiving support on a heart-lung machine.Our long-term goal is to determine if antithrombin (ATIII) can effectively change the coagulation system in patients undergoing heart-lung machine support. The objective of this proposal, which is our first step in pursuit of that goal, is to determine the pharmacokinetics of ATIII in neonates and infants. Our central hypothesis is that ATIII will have different pharmacokinetic properties in neonates and infants than adults and these properties will be affected by the use of heart-lung machine.
This research will result in critical data on the pharmacokinetics of ATIII in neonates and infants receiving heart-lung machine support. This contribution is significant because it is the first step in a continuum of research that is expected to lead to the development of a therapeutic strategy employing ATIII that will facilitate improved modulation of the coagulation cascade to prevent significant clotting and bleeding complications in pediatric patients requiring heart-lung machine support.
Detailed description
This is a single-site, prospective, open-label, pharmacokinetic study of hpATIII in neonates and infants. Patients admitted to the Cardiac Intensive Care Unit (CICU) and the Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC) will be enrolled. Participants will be enrolled into one of three cohorts depending on whether they are scheduled for ECMO, CPB, or neither, and based on age (neonate or infant).
Two doses of hpATIII will be used; one according to current labelling for hpATIII and one that accounts for the additional circuit volume from ECMO or CPB. Pharmacokinetic measurements will be obtained for all groups at baseline prior to administration of hpATIII and at multiple defined times up to 120 hrs following each administration of hpATIII.
Administration of hpATIII is standard of care at CCHMC for participants undergoing ECMO. The standard dose administered for clinical care is (120 - baseline AT activity level) x weight (kg) / 1.4. For participants not undergoing ECMO for clinical care, or for those undergoing ECMO but receiving an adjusted dose for additional circuit volume , the administration of hpATIII is considered research.
The duration of the study at CCHMC is expected to be 2.5 years. This includes 24 months for recruitment and data collection, and 6 months for data analysis and report writing.
Individual participants will be in the study for approximately 120 hours (5 days) following administration of hpATIII. If participants receive more than 1 dose, they will be in the study for approximately 120 hours following each dose of hpATIII received.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | No intervention | –Cohort 1 (Aim 1) - 6 participants Cohort 1 will be comprised of 6 neonates (≤28 days of age) admitted to the CICU or NICU who are neither undergoing ECMO nor CPB. Cohort 1 will receive a single dose of ATIII by short 15 minute infusion. |
| cohort 2.1 | Active comparator | Drug: Antithrombin III• Cohort 2.1 - 6 neonates undergoing ECMO. * Three participants will receive a single dose 15 minute infusion of hpATIII that is dose adjusted to account for additional circuit volume followed by a single dose 15 minute infusion of ATIII that is not dose adjusted to account for circuit volume * Three participants will receive a single dose 15 minute infusion of hpATIII that is not dose adjusted to account for circuit volume followed by a single dose 15 minute infusion of hpATIII that is dose adjusted to account for additional circuit volume |
| cohort 2.2 | Active comparator | Drug: Antithrombin III• Cohort 2.2 - 12 neonates who will undergo open-heart surgery with CPB * Six participants will receive a single dose 15 minute infusion of ATIII that is dose adjusted to account for additional circuit volume. * Six participants will receive a single dose 15 minute infusion of ATIII that is not dose adjusted to account for circuit volume |
| cohort 2.3 | Active comparator | Drug: Antithrombin III• Cohort 2.3 - 12 infants who will undergo open-heart surgery with CPB * Six participants will receive a single dose 15 minute infusion of ATIII that is dose adjusted to account for additional circuit volume. * Six participants will receive a single dose 15 minute infusion of ATIII that is not dose adjusted to account for circuit volume |
| cohort 3 | Active comparator | Drug: Antithrombin IIICohort 3 (Aim 3) - 6 participants Six participants (neonates or infants) who will undergo ECMO and receive ATIII as standard of care will be enrolled and have a baseline ATIII level measured within 6 hours of ATIII administration and repeated within 15 minutes of initiation of extracorporeal support. If post-support level is < 80% normal activity then an ATIII level will be repeated and participants will be assigned to one of two hpATIII dosing regimens in which one formula accounts for additional circuit volume and one formula does not account for additional circuit volume, as described in section 7.4. Upon completion and 120 hr follow up after the first dose, participants still having ATIII activity less than 80% will then receive a second dose |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1. Neonates less than or equal to 28 days of age OR Infants between 29 days and 1 year of age;
- 2. ATIII activity less than 80% at time of screening;
Key exclusion criteria (9 listed)
- Subjects who meet any of the following criteria will be excluded from the study:
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 |
|---|---|---|
| Antithrombin IIIWe are comparing neonates and infants on ECMP or CPB receiving ATIII, the dose of which is calculated to account for circuit volume, and compared with those not accounting for circuit volume | Drug | cohort 2.1, cohort 2.2, cohort 2.3, cohort 3 |
Primary outcome
Aim 1:To determine the pharmacokinetics of a single dose of hpATIII in neonates not undergoing ECMO or CPB.
Time frame: participants in cohort 1 will have sampling up to 36 hrs after receiving their single dose of ATIII
Blood samples (0.5 mL) for analysis of plasma ATIII concentration will be drawn at specific time points, e.g. before and after the dose of ATIII is given ,together with coagulation labs such as prothrombin/ thrombin anti thrombin complex and CBC, PT/PTT/INR at baseline, 12 and 24 hrs only.If clinical labs exist, those will be used instead for that time point.
Aim 2:To determine the pharmacokinetics of a single dose of hpATIII in neonates and infants undergoing ECMO or CPB
Time frame: participants will be followed for 120hrs after recieving their single dose of ATIII
Blood samples (0.5 mL) for analysis of plasma ATIII concentration will be drawn at specific time points, e.g.before and after the dose of ATIII is given,together with coagulation labs such as prothrombin/ thrombin anti thrombin complex and CBC, PT/PTT/INR at baseline, 12 and 24 hrs only. If clinical labs exist, those will be used instead for that time point.
Aim 3:To determine the pharmacokinetics of hpATIII administered by continuous infusion in neonates and infants undergoing ECMO
Time frame: participants will be followed for a period of 120hrs after recieving half the dose as a bolus and the rest as a continuous infusion
Blood samples (0.5 mL) for analysis of plasma ATIII concentration will be drawn at specific time points, e.g.before and after the dose of ATIII is given,together with coagulation labs such as prothrombin/ thrombin anti thrombin complex and CBC, PT/PTT/INR at baseline, 12 and 24 hrs only. If clinical labs exist, those will be used instead for that timepoint.
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 25 Jan 2019.
- Background: PubMed 18227295Guzzetta NA, Bajaj T, Fazlollah T, Szlam F, Wilson E, Kaiser A, Tosone SR, Miller BE. A comparison of heparin management strategies in infants undergoing cardiopulmonary bypass. Anesth Analg. 2008 Feb;106(2):419-25, table of contents. doi: 10.1213/01.ane.0000297290.03501.db.
- Background: PubMed 7341758D'Argenio DZ. Optimal sampling times for pharmacokinetic experiments. J Pharmacokinet Biopharm. 1981 Dec;9(6):739-56. doi: 10.1007/BF01070904.
- Background: PubMed 16281932Esmon CT. The interactions between inflammation and coagulation. Br J Haematol. 2005 Nov;131(4):417-30. doi: 10.1111/j.1365-2141.2005.05753.x.
- Background: PubMed 15999048Avidan MS, Levy JH, van Aken H, Feneck RO, Latimer RD, Ott E, Martin E, Birnbaum DE, Bonfiglio LJ, Kajdasz DK, Despotis GJ. Recombinant human antithrombin III restores heparin responsiveness and decreases activation of coagulation in heparin-resistant patients during cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2005 Jul;130(1):107-13. doi: 10.1016/j.jtcvs.2004.10.045.
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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.
David Cooper, MD principal investigator
Cincinnati Childrens Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Antithrombin III in people with Extracorporeal Membrane Oxygenation Complication and Cardiopulmonary Bypass, run by Children's Hospital Medical Center, Cincinnati 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 9 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 25 Jan 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Aim 1:To determine the pharmacokinetics of a single dose of hpATIII in neonates not undergoing ECMO or CPB. (time frame: participants in cohort 1 will have sampling up to 36 hrs after receiving their single dose of ATIII). The study lists 3 primary outcomes in all. 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 NCT02631174, which also lists 4 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 25 Jan 2019.