Aortic CoarctationNCT01340378
A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt
An observational study of Aortic Coarctation, run by Emory University at 1 site in United States.
Trial summary
The primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Aortic Coarctation
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2014
- 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 Up to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: 1. Full-term neonates (37-42 weeks gestational age) 2. Apgar score of 7 or more at 5 minutes after delivery 3. Surgical placement of BT shunt or repair of an aortic coarctation 4. Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
Who may be able to join
- Full-term neonates (37-42 weeks gestational age)
- Apgar score of 7 or more at 5 minutes after delivery
- Surgical placement of BT shunt or repair of an aortic coarctation
- Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
Who cannot join
- Preterm neonates (less than 37 weeks gestation)
- Apgar score of less than 7 at 5 minutes after birth
- Emergent procedure
- Surgical procedure other than placement of BT shunt or repair of aortic coarctation
- Neonates with a known coagulation defect or coagulopathy
- Mother with a known coagulation defect or coagulopathy
- Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
The primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion.
Read the detailed description
To accomplish our goal, the investigators will measure preoperative levels of one major procoagulant (prothrombin) and one major anticoagulant (Antithrombin). The investigators will also measure preoperative and postoperative thrombelastograms (TEG) and preoperative and postoperative thrombin generation curves (TGC).
- Conditions
- Aortic Coarctation
- Keywords
- neonatal surgery, Blalock-Taussig shunt
- Medical subject headings
- Aortic Coarctation
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin generation - peak amount
The thrombin generating capacity of plasma is measured using a fluorogenic substrate. Coagulation is initiated by contact activation and thrombin generation is monitored by a microplate fluorometer set that displays the progression of the fluorescence reaction. The peak amount of thrombin generated is expressed by absorbancy (nM).
Measured: 2 years
Secondary outcomes (1)
Thrombin Generation Curve validation in neonates
The peak amount of thrombin generated as determined by the thrombin generation curve will be compared to the peak amount of thrombin generated as determined by the thromboelastogram. Both measure thrombin generation by absorbancy (nM).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic CoarctationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's healthcare of Atlanta: Cardiac Research Donor Funds
- Responsible party
- Principal investigator, Nina Guzzetta, M.D., Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340378
- Sponsor's protocol ID
- IRB00034496
- Status last verified
- Dec 2014
- First submitted
- 12 Apr 2011
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt
- ClinicalTrials.gov ID
- NCT01340378
- Acronym / sponsor ID
- IRB00034496
- Conditions
- Aortic Coarctation
- Keywords
- neonatal surgery, Blalock-Taussig shunt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's healthcare of Atlanta: Cardiac Research Donor Funds
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Apr 2011 (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 primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion.
Detailed description
To accomplish our goal, the investigators will measure preoperative levels of one major procoagulant (prothrombin) and one major anticoagulant (Antithrombin). The investigators will also measure preoperative and postoperative thrombelastograms (TEG) and preoperative and postoperative thrombin generation curves (TGC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 1. Full-term neonates (37-42 weeks gestational age) 2. Apgar score of 7 or more at 5 minutes after delivery 3. Surgical placement of BT shunt or repair of an aortic coarctation 4. Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
Key inclusion criteria (4 listed)
- Full-term neonates (37-42 weeks gestational age)
- Apgar score of 7 or more at 5 minutes after delivery
- Surgical placement of BT shunt or repair of an aortic coarctation
- Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
Key exclusion criteria (7 listed)
- Preterm neonates (less than 37 weeks gestation)
- Apgar score of less than 7 at 5 minutes after birth
- Emergent procedure
- Surgical procedure other than placement of BT shunt or repair of aortic coarctation
- Neonates with a known coagulation defect or coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thrombin generation - peak amount
Time frame: 2 years
The thrombin generating capacity of plasma is measured using a fluorogenic substrate. Coagulation is initiated by contact activation and thrombin generation is monitored by a microplate fluorometer set that displays the progression of the fluorescence reaction. The peak amount of thrombin generated is expressed by absorbancy (nM).
1 secondary outcome
Thrombin Generation Curve validation in neonates
Time frame: 2 years
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 12 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Coarctation, run by Emory University 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 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: finished, as of the sponsor's last update on 12 Dec 2014. 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 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?
Thrombin generation - peak amount (time frame: 2 years). 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 12 Dec 2014.