Congenital Heart DiseaseCOMPAXE-HNFNCT07365670
Comparison of the Best Method for Measuring Anti-Xa Activity in Children Receiving Unfractionated Heparin in Cardiac Intensive Care (COMPAXE-HNF)
A study testing blood sampling for measuring anti-Xa activity and measurement of anti-XA activity in people with Congenital Heart Disease and Unfractionated Heparin, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
This study aims to compare the accuracy of two different blood sampling methods from a central venous catheter (CVC) for measuring anti-Xa activity in children receiving unfractionated heparin (UFH) from this CVC. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Congenital Heart Disease, Unfractionated Heparin, Anti Xa Activity
- What is being tested?
- blood sampling for measuring anti-Xa activity and measurement of anti-XA activity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Minors aged 0 to 17 inclusive
- Weight greater than or equal to 3.5 kg
- Admitted to resuscitation or congenital cardiac intensive care
- Requiring treatment with unfractionated heparin at curative doses administered via central venous access
- Equipped with a central arterial and venous catheter
- Affiliated with or beneficiary of a social security scheme
- Free, informed, and written consent signed by one of the two representatives of parental authority and the investigator (no later than the day of inclusion and before any examination required by the research).
Who cannot join
- Newborns < 37 weeks gestation
- Patients treated by a humanitarian organization
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to compare the accuracy of two different blood sampling methods from a central venous catheter (CVC) for measuring anti-Xa activity in children receiving unfractionated heparin (UFH) from this CVC. The results will be compared to a "gold standard" sample taken from an arterial catheter (KTA) whithout UFH. The objective is to identify a more reliable method for monitoring UFH, thereby reducing the risk of bleeding or thrombosis in these patients.
Read the detailed description
- Scientific Justification: UFH is widely used in pediatric cardiac intensive care for its short half-life and availability of an antidote. However, monitoring its effect via anti-Xa activity is challenging. The standard method of sampling from a CVC is known to be prone to heparin contamination, leading to inaccurate results (over- or under-anticoagulation). This lack of precision can lead to dangerous complications like major bleeding or thrombotic events. As studies by Palermo et al. (1980) and Bauman et al. (2012) have shown, the unreliability of CVC samples justifies the search for a safer alternative. The arterial catheter (KTA) provides a contamination-free "gold standard," making it the ideal comparison for evaluating the more reliable sampling method.
- Procedure: The study will compare two CVC sampling methods (a standard flush protocol and a new experimental method) against the gold standard (KTA sampling without UFH)
- Follow-up: The study will be conducted over three consecutive days. Each day, three sets of blood samples will be collected every 6 hours per patient (KTA, standard CVC, and experimental CVC).
- Being tested
- blood sampling for measuring anti-Xa activity, measurement of anti-XA activity
- Keywords
- Unfractionated Heparin, Anti-Xa activity, Pediatric Intensive Care, Congenital Heart Disease, Blood Sampling, Central Venous Catheter, Arterial Catheter, Thrombosis, Hemostasis.
- Medical subject headings
- Heart Defects, Congenital, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling for measuring anti-Xa activityProcedure or surgery
Each patient included in the study will have a series of three samples taken every 4 hours for 3 days:
- Sample taken from a non-heparinized arterial catheter (Gold Standard), performed as part of routine care: Method ①
- Sample taken from a central venous catheter without stopping the HNF: Method ②
- Sampling from a central venous catheter with an HNF pause: Method ③
At each anti-Xa activity check in the included patients, the nurse will take the 3 blood samples.
The order in which samples ② and ③ are taken will be determined by randomization.
measurement of anti-XA activityProcedure or surgery
Each patient will have, each time that anti-Xa activity needs to be measured, three successive samples taken:
- Sample taken from a non-heparinized arterial catheter (gold standard), performed as part of routine care: Method ①
- Sample taken from a central venous catheter without stopping the HNF: Method ②
- Sample from central venous catheter with HNF pause: Method ③
| Study group | Role | What they receive |
|---|---|---|
| anti-Xa activity monitoring | Experimental | All patients included in the study Receives: Procedure: blood sampling for measuring anti-Xa activity; Procedure: measurement of anti-XA activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of anti-Xa activity (in IU/mL) from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard).
Anti-Xa activity and APTT measurements will be performed at the university hospital's central laboratory, which guarantees the consistency of the reagents, automated systems, and techniques used.
The recommended therapeutic target is between 0.3 and 0.6 IU/mL.
Measured: "From enrollment to the end of study at 72hours"
Secondary outcomes (2)
Measurement of APTT from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard).
Activated partial thromboplastin time (APTT):
Mainly used in the United States and in some French intensive care units, the APTT provides an overall assessment of the activity of several coagulation factors: factor I (or fibrinogen), factor II (or prothrombin), factor V, factor VIII, factor IX, factor X, factor XI, and factor XII. (Figure 1) The APTT is a measure of blood clotting time. It is expressed as a ratio between the patient's APTT and a "control" APTT, which is that of the laboratory. It is expressed in seconds.
Normal values for the patient APTT/control APTT ratio are between 0.80 s and 1.20 s.
- Above this range: the risk of bleeding increases.
- Below this range: treatment is ineffective, with a risk of clot formation.
Measured: "From enrollment to the end of study at 72 hours"
Measurement of APTT and anti-Xa activity (in IU/mL) from a sample taken from a non-heparinized arterial catheter (i.e., gold standard)
The TCA measurement is performed in the same way.
Measured: From enrollment to the end of study at 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an interventional, prospective, single-center (pediatric congenital cardiac intensive care unit at the Réunion University Hospital, North site) study of diagnostic performance. * Comparison procedure: sampling from a non-heparinized arterial catheter (gold standard), performed as part of routine care: Method ① * Experimental procedure, performed as part of the research: two samples taken from a central venous catheter (CVC) * Sample taken from central venous catheter without HNF pause: Method ② * Sample taken from central venous catheter with HNF pause: Method ③ At each anti-Xa activity check in the patients included, the IDE will take the 3 blood samples. The order in which samples ② and ③ are taken will be determined by randomization. The laboratory will be blinded to the sampling method in order to guarantee the objectivity of the results.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365670
- Sponsor's protocol ID
- 2025/RUN/0031
- Other IDs
- Ethics Committee
- Acronym
- COMPAXE-HNF
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Best Method for Measuring Anti-Xa Activity in Children Receiving Unfractionated Heparin in Cardiac Intensive Care (COMPAXE-HNF)
- ClinicalTrials.gov ID
- NCT07365670
- Acronym / sponsor ID
- COMPAXE-HNF / 2025/RUN/0031
- Keywords
- Unfractionated Heparin, Anti-Xa activity, Pediatric Intensive Care, Congenital Heart Disease, Blood Sampling, Central Venous Catheter, Arterial Catheter, Thrombosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 26 Jan 2026 (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.
This study aims to compare the accuracy of two different blood sampling methods from a central venous catheter (CVC) for measuring anti-Xa activity in children receiving unfractionated heparin (UFH) from this CVC. The results will be compared to a "gold standard" sample taken from an arterial catheter (KTA) whithout UFH. The objective is to identify a more reliable method for monitoring UFH, thereby reducing the risk of bleeding or thrombosis in these patients.
Detailed description
- Scientific Justification: UFH is widely used in pediatric cardiac intensive care for its short half-life and availability of an antidote. However, monitoring its effect via anti-Xa activity is challenging. The standard method of sampling from a CVC is known to be prone to heparin contamination, leading to inaccurate results (over- or under-anticoagulation). This lack of precision can lead to dangerous complications like major bleeding or thrombotic events. As studies by Palermo et al. (1980) and Bauman et al. (2012) have shown, the unreliability of CVC samples justifies the search for a safer alternative. The arterial catheter (KTA) provides a contamination-free "gold standard," making it the ideal comparison for evaluating the more reliable sampling method.
- Procedure: The study will compare two CVC sampling methods (a standard flush protocol and a new experimental method) against the gold standard (KTA sampling without UFH)
- Follow-up: The study will be conducted over three consecutive days. Each day, three sets of blood samples will be collected every 6 hours per patient (KTA, standard CVC, and experimental CVC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an interventional, prospective, single-center (pediatric congenital cardiac intensive care unit at the Réunion University Hospital, North site) study of diagnostic performance. * Comparison procedure: sampling from a non-heparinized arterial catheter (gold standard), performed as part of routine care: Method ① * Experimental procedure, performed as part of the research: two samples taken from a central venous catheter (CVC) * Sample taken from central venous catheter without HNF pause: Method ② * Sample taken from central venous catheter with HNF pause: Method ③ At each anti-Xa activity check in the patients included, the IDE will take the 3 blood samples. The order in which samples ② and ③ are taken will be determined by randomization. The laboratory will be blinded to the sampling method in order to guarantee the objectivity of the results.
| Arm | Type | Receives |
|---|---|---|
| anti-Xa activity monitoring | Experimental | Procedure: blood sampling for measuring anti-Xa activity, Procedure: measurement of anti-XA activityAll patients included in the study |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Minors aged 0 to 17 inclusive
- Weight greater than or equal to 3.5 kg
- Admitted to resuscitation or congenital cardiac intensive care
- Requiring treatment with unfractionated heparin at curative doses administered via central venous access
- Equipped with a central arterial and venous catheter
Key exclusion criteria (2 listed)
- Newborns < 37 weeks gestation
- Patients treated by a humanitarian organization
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 |
|---|---|---|
| blood sampling for measuring anti-Xa activityEach patient included in the study will have a series of three samples taken every 4 hours for 3 days: * Sample taken from a non-heparinized arterial catheter (Gold Standard), performed as part of routine care: Method ① * Sample taken from a central venous catheter without stopping the HNF: Method ② * Sampling from a central venous catheter with an HNF pause: Method ③ At each anti-Xa activity check in the included patients, the nurse will take the 3 blood samples. The order in which samples ② and ③ are taken will be determined by randomization. | Procedure or surgery | anti-Xa activity monitoring |
| measurement of anti-XA activityEach patient will have, each time that anti-Xa activity needs to be measured, three successive samples taken: * Sample taken from a non-heparinized arterial catheter (gold standard), performed as part of routine care: Method ① * Sample taken from a central venous catheter without stopping the HNF: Method ② * Sample from central venous catheter with HNF pause: Method ③ | Procedure or surgery | anti-Xa activity monitoring |
Primary outcome
Measurement of anti-Xa activity (in IU/mL) from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard).
Time frame: "From enrollment to the end of study at 72hours"
Anti-Xa activity and APTT measurements will be performed at the university hospital's central laboratory, which guarantees the consistency of the reagents, automated systems, and techniques used. The recommended therapeutic target is between 0.3 and 0.6 IU/mL.
2 secondary outcomes
Measurement of APTT from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard).
Time frame: "From enrollment to the end of study at 72 hours"
Measurement of APTT and anti-Xa activity (in IU/mL) from a sample taken from a non-heparinized arterial catheter (i.e., gold standard)
Time frame: From enrollment to the end of study at 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling for measuring anti-Xa activity and measurement of anti-XA activity in people with Congenital Heart Disease and Unfractionated Heparin, run by Centre Hospitalier Universitaire de la Réunion.
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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie CONEAU (+262693829524, marieconeau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of anti-Xa activity (in IU/mL) from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard). (time frame: "From enrollment to the end of study at 72hours"). 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 21 Sep 2026.