Bleeding Prediction in Thrombocytopenia

Thrombocytopenia Clinical Trial

Official title:

Bleeding Prediction in Thrombocytopenia Using Platelet Indices, Platelet Aggregometry and a Standardized Bleeding Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306044
• Other study ID #: s-20120088
• Status: Completed
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to investigate whether platelet indices from automated haematology equipment, whole blood impedance aggregometry and a standardized bleeding questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes.

Description:

Thrombocytopenia is a risk factor for bleeding, but studies concerning markers for stratification of bleeding risk among thrombocytopenic patients are lacking. This prospective observational cohort study investigates risk factor for bleeding in admitted patients with thrombocytopenia of various causes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Admitted patients with thrombocytopenia

• Age =18 years

• Platelet count below 80 x109/L

Exclusion Criteria:

• Platelet transfusion within the previous 14 days,

• surgery or trauma within the previous 7 days

• Unable to give informed consent.

Related Conditions & MeSH terms

• Hemorrhage
• Thrombocytopenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pernille Just Vinholt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean platelet volume	Mean platelet volume (femtolitre (fL))	30 days
Secondary	Platelet count	Platelet count ( x10'9/L)	30 days
Secondary	immature platelet fraction	immature platelet fraction (%)	30 days
Secondary	Bleeding questionnaire	Bleeding score based on the condensed MCMDM-1 VWD bleeding questionnaire	30 days
Secondary	Platelet aggregation	Platelet aggregation by Multiplate Analyzer (aggregation units* min)	30 days