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Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)

Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01138618
Acronym
CHEMPAQ
Enrollment
85
Registered
2010-06-07
Start date
2010-04-30
Completion date
2011-05-31
Last updated
2011-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Clozapine, hematological monitoring, CHEMPAQ, Granulocytes, WBC

Brief summary

Clozapine remain the drug of choice for treatment resistant schizophrenia and up to 60% of patients not responding to other antipsychotics will respond to clozapine. However, the use of clozapine is restricted due to the risk of agranulocytosis and consequently the need for mandatory hematological monitoring. CHEMPAQ XBC is a point-of-care device that can be used in patients home and analyze WBC and granulocytes by a single capillary blood drop. This study aims to investigate whether this new procedure increases the acceptability of clozapine

Interventions

DEVICEVenous blod sample

Regular venous blood sample withdrawn from the laboratory

DEVICECHEMPAQ

Capillary blood sample analyzed by CHEMPAQ

Sponsors

Aalborg Psychiatric Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Treated with clozapine * Compliant with blood monitoring * Willing to give informed consent

Exclusion criteria

* Prior case of agranulocytosis

Design outcomes

Primary

MeasureTime frameDescription
Pain sensationMonthly for four monthsPain sensation was measured using a visual analog scale (VAS)

Secondary

MeasureTime frameDescription
The benefits of CHEMPAQMonthly for four monthsCaregivers and patients were asked about the benefits of using CHEMPAQ for hematological clozapine monitoring.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026