Cardiopulmonary BypassNCT01352143
Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass
An observational study of Cardiopulmonary Bypass, run by Emory University at 1 site in United States.
Trial summary
The primary goal of this investigation is to determine the ability of recombinant activated factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to improve thrombin generation in neonatal plasma after CPB. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- Recombinant activated factor VII and Prothrombin Complex Concentrate
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2012
- 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: Neonates (less than 30 days of age) undergoing complex congenital cardiac surgery requiring cardiopulmonary bypass
Who may be able to join
- Full-term neonates (36-42 weeks gestational age)
- Apgar score of 7 or more at 5 minutes after delivery
- Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta at Egleston
- Parents willing to participate, and able to understand and sign the provided informed consent
Who cannot join
- Preterm neonates (less than 36 weeks gestation)
- Apgar score of less than 6 at 5 minutes after birth
- Emergent procedure
- Patients undergoing cardiac surgery not requiring CPB
- Neonates with a known coagulation defect or coagulopathy
- Mother with a known coagulation defect or coagulopathy
- Parents 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
Atlanta, Georgia, 30322
About this study
Official title: Measurements of Thrombin Generation in Response to Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Neonatal Plasma After Cardiopulmonary Bypass
The primary goal of this investigation is to determine the ability of recombinant activated factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to improve thrombin generation in neonatal plasma after CPB.
Read the detailed description
In this investigation, the investigators propose a comparison in vitro of the ability of rFVIIa with that of PCC to increase thrombin generation in neonatal plasma after CPB. A pre-cardiopulmonary bypass (CPB) baseline blood sample will be obtained. After the termination of CPB and the administration of one round of protamine, platelets and fibrinogen (standard of care), a second blood sample will be drawn. All samples will be centrifuged to yield platelet rich plasma and stored until processing. In the pre-CPB sample, baseline thrombin generation will be measured. The post-CPB sample will be divided into three aliquots to measure thrombin generation under three different circumstances: the first will serve as a control, the second will include rFVIIa and the third PCC.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Recombinant activated factor VII, Prothrombin Complex Concentrate
- Keywords
- Neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant activated factor VIIDrug
Also called NovoSeven RT, Novo Nordisk, Bagsvaerd, Denmark
Plasma will be spiked in vitro with recombinant activated factor VII to assess increases in thrombin generation with and without the drug
Prothrombin Complex ConcentrateDrug
Also called Beriplex P/N, CSL Behring, King of Prussia, PA
Plasma will be spiked in vitro with prothrombin complex concentrate to determine increases in thrombin generation with and without the drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak thrombin Generation
The primary outcome measure is the peak amount of thrombin generated (measured in nM) as determined by the Thrombinoscope with rFVIIa as compared to PCC.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Research Oversight Committee Funds
- Responsible party
- Principal investigator, Nina Guzzetta, M.D., Emory University
- Investigators
- Nina A Guzzetta, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352143
- Sponsor's protocol ID
- IRB00048151
- Status last verified
- Nov 2013
- First submitted
- 20 Apr 2011
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Thrombin Generation in Response to Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Neonatal Plasma After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01352143
- Acronym / sponsor ID
- IRB00048151
- Conditions
- Cardiopulmonary Bypass
- Keywords
- Neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Research Oversight Committee Funds
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 May 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 determine the ability of recombinant activated factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to improve thrombin generation in neonatal plasma after CPB.
Detailed description
In this investigation, the investigators propose a comparison in vitro of the ability of rFVIIa with that of PCC to increase thrombin generation in neonatal plasma after CPB. A pre-cardiopulmonary bypass (CPB) baseline blood sample will be obtained. After the termination of CPB and the administration of one round of protamine, platelets and fibrinogen (standard of care), a second blood sample will be drawn. All samples will be centrifuged to yield platelet rich plasma and stored until processing. In the pre-CPB sample, baseline thrombin generation will be measured. The post-CPB sample will be divided into three aliquots to measure thrombin generation under three different circumstances: the first will serve as a control, the second will include rFVIIa and the third PCC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates (less than 30 days of age) undergoing complex congenital cardiac surgery requiring cardiopulmonary bypass
Key inclusion criteria (4 listed)
- Full-term neonates (36-42 weeks gestational age)
- Apgar score of 7 or more at 5 minutes after delivery
- Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta at Egleston
- Parents willing to participate, and able to understand and sign the provided informed consent
Key exclusion criteria (7 listed)
- Preterm neonates (less than 36 weeks gestation)
- Apgar score of less than 6 at 5 minutes after birth
- Emergent procedure
- Patients undergoing cardiac surgery not requiring CPB
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant activated factor VIIAlso: NovoSeven RT, Novo Nordisk, Bagsvaerd, DenmarkPlasma will be spiked in vitro with recombinant activated factor VII to assess increases in thrombin generation with and without the drug | Drug | – |
| Prothrombin Complex ConcentrateAlso: Beriplex P/N, CSL Behring, King of Prussia, PAPlasma will be spiked in vitro with prothrombin complex concentrate to determine increases in thrombin generation with and without the drug | Drug | – |
Primary outcome
Peak thrombin Generation
Time frame: one year
The primary outcome measure is the peak amount of thrombin generated (measured in nM) as determined by the Thrombinoscope with rFVIIa as compared to PCC.
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 20 Nov 2013.
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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.
Nina A Guzzetta, M.D. principal investigator
Emory University
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 Cardiopulmonary Bypass, 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 20 Nov 2013. 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?
Peak thrombin Generation (time frame: one year). 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 20 Nov 2013.