Bleeding Prediction in Thrombocytopenia

Completed

• Conditions: Thrombocytopenia

• Registration Number: NCT02306044
• Lead Sponsor: Pernille Just Vinholt

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean platelet volume	30 days	Mean platelet volume (femtolitre (fL))

Secondary Outcome Measures

Name	Time	Method
Bleeding questionnaire	30 days	Bleeding score based on the condensed MCMDM-1 VWD bleeding questionnaire
Platelet count	30 days	Platelet count ( x10'9/L)
immature platelet fraction	30 days	immature platelet fraction (%)
Platelet aggregation	30 days	Platelet aggregation by Multiplate Analyzer (aggregation units\* min)