An interventional study of Accuvein V400 device and Routine procedure in Sickle Cell Crisis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-13.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
Among 12 studies in Vaso-Occlusive Crises by Assistance Publique - Hôpitaux de Paris — 5 open to participants now, 5 under way, 1 of them phase 3. Vaso-Occlusive Crises · Assistance Publique - Hôpitaux de Paris.
Among the 12 studies in Vaso-Occlusive Crises by Assistance Publique - Hôpitaux de Paris, this one is the 3rd largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2018, is one of 7 with no phase, and was the 3rd registered.
104 studies on the registry are indexed under Vaso-Occlusive Crises; 31 are open to participants now.
Browse Vaso-Occlusive Crises studies →5 of the 12 studies in Vaso-Occlusive Crises by Assistance Publique - Hôpitaux de Paris are open now, in 1 country. Recruiting first, the newest first:
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 12–35
Assistance Publique - Hôpitaux de Paris
Ages 18+
Assistance Publique - Hôpitaux de Paris
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 12–35
Assistance Publique - Hôpitaux de Paris
Ages up to 18
By country, each count listing its studies:
Of the 17 Vaso-Occlusive Crises studies recruiting now, 7 (41%) set no upper age limit and 6 (35%) stop at 75 or younger; 10 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 2 · Phase 4 1
First in 2011; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 126 is above the median of 81 across 86 interventional studies indexed under Vaso-Occlusive Crises.
Median enrollment 40 across the 11 interventional studies, 200 across the 1 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Vaso-Occlusive Crises by Assistance Publique - Hôpitaux de Paris, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The primary goal of this randomized, controlled, open-label study is to determine the efficacy of AccuveinV400 (a transillumination veins device) to facilitate peripheral intravenous (IVP) catheter placement during a vaso-oclusive crisis. The investigators hypothesized that the number of attempts to a successful placement of a peripheral IV, our primary outcome, would be shorter with the assistance of the Accuvein V400. It is also expected that AccuveinV400 will reduce the time of the procedure, the rate of failure, the technique-related pain.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the Accuvein group, the nurse uses the Accuvein device to identify the veins before any puncture to infuse the patient and then proceeds as usual, under illumination of the device.
Device: Accuvein V400 device
In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)
Other: Routine procedure
Sickle cell patients who need a new vein puncture in order to infuse them will benefit of AccuveinV400 device to illuminate their venous network
In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)
Number of venipunctures
Number of venipunctures until the peripheral IV placement (with a retrograde blood sample) or before failure (discontinuation after at least 3 attempts by 2 nurses and a maximum of 9 attempts in total).
Time frame: Time of the infusion procedure
Time of the procedure
Time from the tourniquet inflation to the insertion of the catheter with a retrograde blood sample was recorded with a chronometer
Time frame: Time of the infusion procedure
Procedure failure
Percentage of the procedure failure
Time frame: Time of the infusion procedure
The need of a central venous catheter
Percentage of use of a central venous catheter due to failure of peripheral perfusion.
Time frame: Time of the infusion procedure
Patient bone pain before and after the procedure
Patient bone pain will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain) before and after the infusion procedure
Time frame: Before and within 1 hour after a successful peripheral IV placement
Anxiety before and after the procedure
Patient and nurse anxiety will be evaluated by a visual 5 points-Likert scale (between 1=not at all anxiety to 5=extremely anxious) of anxiety before and after the procedure
Time frame: Just before and within 1 hour after a successful peripheral IV placement
Patient satisfaction (pain)
Patient pain related to the procedure will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain)
Time frame: Within 1 hour after a successful peripheral IV placement
Patient satisfaction (procedure)
Patient satisfaction of the procedure will be evaluated by a visual 5-points Likert scale (between 1=not at all anxiety to 5=extremely anxious) of satisfaction of the procedure
Time frame: Within 1 hour after a successful peripheral IV placement
Nurse satisfaction (procedure)
Nurse global satisfaction of the procedure will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)
Time frame: Within 1 hour after a successful peripheral IV placement
Nurse satisfaction (quality of placement)
Nurse satisfaction of the quality of the peripheral intravenous placement will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)
Time frame: Within 1 hour after a successful peripheral IV placement
Qualitative interview of the Accuvein use
Verbatim of a semi-structured interview by a psychologist of 10 to 15 patients (and their nurse) often hospitalized, in the Accuvein Arm
Time frame: An average of one week after the procedure
Side effects of the procedure
Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise).
Time frame: Time of the infusion procedure
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Apr 2022, 49 months.
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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