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Valproate: A drug with multiple uses and risk of bleeding tendency

Association of Thrombocytopenia with Valproic Acid Treatment: A Follow-up Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/02/017552
Enrollment
50
Registered
2019-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patient on treatment with Valproic acid or Divalproex Sodium

Interventions

None listed

Sponsors

Gujarat Cancer Society Medical College Hospital and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient should be on treatment with valproic acid or divalproex sodium for a period of 6 months. Patient must be willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients already diagnosed with medical illness known to cause thrombocytopenia like vitamin B12 deficiency, active alcohol dependence, renal failure, leukemias and lymphomas, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura etc. 2) Patients on treatment with other drugs known to cause thrombocytopenia like carbamazapine, phenytoin, diclofenac, ibuprofen, cimetidine, ranitidine, quinine, rifampicin, vancomycin, ampicillin, trimethoprim+sulfamethaxozole, chlorpropamide etc.

Design outcomes

Primary

MeasureTime frame
Primary outcome is to find out the percentage of patients on valproic acid treatment developing thrombocytopenia. For the study purpose platelet counts less than 1,50,000/cumm will be defined as thrombocytopeniaTimepoint: Platelets counts of the patients will be measured at baseline (6 months) and monthly thereafter for a period of 3 months i.e. at 7 month, 8 month and 9 month.

Secondary

MeasureTime frame
Secondary outcome is to study the correlation between the dose of valproic acid used (in mg/kg) with thrombocytopenia (platelet counts less than 1,50,000/cumm).Timepoint: At 6 month, 7 month, 8 month, 9 month.

Countries

India

Contacts

Public ContactDr Harshil Chauhan

Gujarat Cancer Society Medical College, Hospital and Research Centre, Ahmedabad

harshells4u@gmail.com9979137788

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026