Congenital Heart DiseaseNCT01914211
The Role of Tranexamic Acid in Reducing Blood Transfusion Requirements After Cardiopulmonary Bypass in Neonates
An observational study of Congenital Heart Disease, run by Aymen N Naguib at 1 site in United States.
Trial summary
This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Tranexamic Acid and Acute Normovolemic Hemodilution
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Patients from the cardiothoracic surgery population at Nationwide Children's Hospital.
Who may be able to join
- All neonates undergoing arterial switch or aortic arch procedure utilizing cardiopulmonary bypass (CPB).
Who cannot join
- Jehovah's witness patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass.
- Conditions
- Congenital Heart Disease
- Being tested
- Tranexamic Acid, Acute Normovolemic Hemodilution
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
100mg/kg prior to incision, 100mg/kg on CPB and 100mg/kg after reversal of heparin with protamine.
Acute Normovolemic HemodilutionProcedure or surgery
Draw 20 mL/kg (up to 5Kg) of blood from patient and replace with washed PRBCs at 10-20mL/kg. (If > 5Kg draw 20% of circulating blood volume without PRBC replacement)
| Study group | Role | What they receive |
|---|---|---|
| Acute Normovolemic Hemodilution | Patients that receive acute normovolemic hemodilution prior to surgery. Receives: Procedure: Acute Normovolemic Hemodilution | |
| Tranexamic Acid | Patients that receive tranexamic acid during surgery. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of postoperative hemostasis
Evaluating the body's ability to stop or decrease postoperative bleeding.
Measured: 24 hours
Secondary outcomes (1)
Volume of blood transfusions
Assessing the need for and amount of blood transfusions during the 1st 24 hours post-op.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aymen N Naguib
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aymen N Naguib, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914211
- Sponsor's protocol ID
- IRB13-00350
- Status last verified
- Jan 2017
- First submitted
- 31 Jul 2013
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Tranexamic Acid in Reducing Blood Transfusion Requirements After Cardiopulmonary Bypass in Neonates
- ClinicalTrials.gov ID
- NCT01914211
- Acronym / sponsor ID
- IRB13-00350
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aymen N NaguibUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Aug 2013 (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.
This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Normovolemic Hemodilution | – | Procedure: Acute Normovolemic HemodilutionPatients that receive acute normovolemic hemodilution prior to surgery. |
| Tranexamic Acid | – | Drug: Tranexamic AcidPatients that receive tranexamic acid during surgery. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients from the cardiothoracic surgery population at Nationwide Children's Hospital.
Key inclusion criteria (1 listed)
- All neonates undergoing arterial switch or aortic arch procedure utilizing cardiopulmonary bypass (CPB).
Key exclusion criteria (1 listed)
- Jehovah's witness patients.
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 |
|---|---|---|
| Tranexamic Acid100mg/kg prior to incision, 100mg/kg on CPB and 100mg/kg after reversal of heparin with protamine. | Drug | Tranexamic Acid |
| Acute Normovolemic HemodilutionDraw 20 mL/kg (up to 5Kg) of blood from patient and replace with washed PRBCs at 10-20mL/kg. (If > 5Kg draw 20% of circulating blood volume without PRBC replacement) | Procedure or surgery | Acute Normovolemic Hemodilution |
Primary outcome
Level of postoperative hemostasis
Time frame: 24 hours
Evaluating the body's ability to stop or decrease postoperative bleeding.
1 secondary outcome
Volume of blood transfusions
Time frame: 24 hours
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 1 Feb 2017.
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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 Congenital Heart Disease, run by Aymen N Naguib 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 1 inclusion and 1 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 1 Feb 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?
Level of postoperative hemostasis (time frame: 24 hours). 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 1 Feb 2017.