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The goal is to investigate whether blood samples drawn from a central venous catheter can provide reliable measurements of unfractionated heparin (UFH) anti-Xa activity, compared to the standard method of peripheral vein puncture, in intensive care unit (ICU) patients receiving continuous intravenous UFH.
To evaluate the reliability of central venous blood sampling, the study will compare anti-Xa activity levels obtained simultaneously from two different types of blood draws: one from a peripheral vein (reference method), and the other from the central line using one of two flushing techniques.
The two central flushing techniques being studied are:
Each patient will undergo four pairs of simultaneous blood draws, using both central techniques in a randomized sequence. The main objective is to assess whether the anti-Xa levels from central samples are equivalent to those from peripheral vein puncture, with a predefined margin of equivalence of ±0.05 IU/mL.
Findings from this study may support the use of central venous catheters for routine anti-Xa monitoring in ICU patients, potentially avoiding painful or technically difficult peripheral vein punctures.
Unfractionated heparin (UFH) is widely used in intensive care units (ICUs) and requires close monitoring, most commonly through the measurement of anti-Xa activity.
The reference method for anti-Xa monitoring involves blood sampling by peripheral vascular puncture. However, in ICU patients, peripheral access may be challenging or painful, and central venous catheters are often available and already used for UFH infusion. Sampling from these central lines could be a convenient alternative, but residual heparin in the catheter may contaminate the sample, leading to falsely elevated anti-Xa results.
The CASSANDRA study (Central catheter Anti-Xa Sampling Study for Accurate aNalysis and Reliable Dosage Assessment) is a prospective, monocentric, comparative study designed to assess whether anti-Xa activity levels obtained from central venous catheter samples are equivalent to those from peripheral vein samples.
To be eligible for inclusion, patients must already have a central venous catheter in place and require continuous intravenous unfractionated heparin administration through the distal lumen of the central venous catheter.
A three-way stopcock will be placed upstream of the infusion tubing to allow temporary interruption of UFH infusion during sampling.
Two catheter flushing techniques will be compared:
For each patient, four pairs of simultaneous blood samples will be collected, according to a randomized sequence alternating between methods A and B. In each pair, one sample will be drawn from the central venous catheter and the other from a fresh peripheral vein puncture (reference). All anti-Xa assays will be performed, but only the results from peripheral vein samples (reference method) will be made available to clinicians. Anti-Xa results from central venous catheter samples will remain blinded to the clinical team to avoid influencing patient management.
The primary outcome is the absolute difference in anti-Xa activity between central venous catheter samples (either method) and peripheral samples. Equivalence is defined as a mean difference not exceeding 0.05 IU/mL. Secondary outcomes include Bland-Altman agreement limits between each central method and the peripheral reference.
Results of this study may support the safe use of central venous sampling for routine anti-Xa monitoring in ICU patients, provided an appropriate flushing method is used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A, B, A, B | Experimental | First and third samples with syringe flush; second and fourth with vacuum tube flush |
|
| Sequence A, B, B, A | Experimental | First and fourth samples with syringe flush; second and third with vacuum tube flush |
|
| Sequence B, A, B, A | Experimental | Second and fourth samples with syringe flush; first and third with vacuum tube flush |
|
| Sequence B, A, A, B | Experimental | Second and third samples with syringe flush; first and fourth with vacuum tube flush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter flushing techniques | Procedure | Two catheter flushing techniques will be compared:
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in anti-Xa activity values between the two sampling sites. | Difference in anti-Xa activity values between the two sampling sites: central venous catheter with a 5 mL discard using either a syringe or a vacuum tube, versus peripheral vein puncture, the latter being considered the reference method. Equivalence is defined a priori as a mean absolute difference not exceeding 0.05 IU/mL of anti-Xa activity. | From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence of anti-Xa activity measurements between central venous catheter sampling using flush method A (5 mL syringe discard) and peripheral vein puncture. | Agreement limits of anti-Xa activity measurements between central venous catheter sampling using flush method A and peripheral vein puncture. | From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Types and durations of organ support therapies | Organ support requirements, including number of days on mechanical ventilation, renal replacement therapy, or extracorporeal membrane oxygenation (ECMO). | From enrollment to Day 28 or discharge (whichever comes first) |
| Thromboembolic and bleeding complications |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregoire MULLER, Dr | Contact | +33238229534 | gregoire.muller@chu-orleans.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gregoire MULLER, Dr | CHU Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Orleans | Recruiting | Orléans | 45067 | France |
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| Equivalence of anti-Xa activity measurements between central venous catheter sampling using flush method B (5 mL vacuum tube discard) and peripheral vein puncture. | Agreement limits of anti-Xa activity measurements between central venous catheter sampling using flush method B and peripheral vein puncture. In both cases, the anti-Xa activity measured from the peripheral vein is considered the reference | From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28 |
Description of thrombotic and bleeding complications during the ICU stay, with bleeding events graded according to ISTH severity criteria. |
| From enrollment to Day 28 or discharge (whichever comes first) |
| Types of blood products transfused | Type of blood products transfused (red blood cells, frozen plasma, platelets) during the ICU stay will be recorded. | From enrollment to Day 28 or discharge (whichever comes first) |
| Number of blood products transfused | Number of blood products transfused during the ICU stay. | Day 28 or discharge (whichever comes first) |
| Volumes of blood products transfused | Volume of blood products transfused during the ICU stay. | Day 28 or discharge (whichever comes first) |
| Inflammatory status, as reflected by fibrinogen levels. | Fibrinogen level | Day 28 or discharge (whichever comes first) |
| Inflammatory status, as reflected by platelet levels. | Platelets count | Day 28 or discharge (whichever comes first) |
| Total dose of protamine administered during the ICU stay | Day 28 or discharge (whichever comes first) |
| Hemoglobin variations during the ICU stay | Day 28 or discharge (whichever comes first) |
| Number and values of anti-Xa UFH assays performed | Day 28 or discharge (whichever comes first) |
| Vital status at ICU discharge | Vital status (alive or deceased) assessed at the time of intensive care unit (ICU) discharge, based on the final medical record and discharge summary. | Up to 6 months |
| Number of discrepancies between therapeutic actions | Comparison of the number of discrepancies between therapeutic actions (i.e., heparin dose adjustments based on the unit's therapeutic protocol) undertaken in response to anti-Xa results obtained from the reference method (peripheral vein puncture) and those that would have been undertaken if anti-Xa results from central venous catheter samples had been used. | From inclusion to Day 28 |
| Reason for ICU admission | Descriptive classification of the primary reason for ICU admission, based on the initial diagnosis recorded in the patient's medical chart at inclusion. | From enrollment to Day 28 or discharge (whichever comes first) |
| Indication for anticoagulation | Descriptive classification of the medical indication for initiating therapeutic anticoagulation with unfractionated heparin (e.g., venous thromboembolism, atrial fibrillation, extracorporeal support, etc.) as recorded at ICU admission. | From enrollment to Day 28 or discharge (whichever comes first) |
| Types and durations of organ support therapies | Number of days each organ support therapy was used during the ICU stay, including mechanical ventilation, renal replacement therapy, vasopressors, or extracorporeal membrane oxygenation (ECMO), as documented in the medical record. | From enrollment to Day 28 or discharge (whichever comes first) |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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