Bleeding Prediction in Thrombocytopenia

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

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.

Study Overview

• Status: Completed
• Conditions: Thrombocytopenia

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 Type: Observational
• Enrollment (Actual): 280

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Admitted patients with thrombocytopenia of any cause

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean platelet volume	Mean platelet volume (femtolitre (fL))	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pernille Just Vinholt
• Investigators: Principal Investigator: Pernille J Vinholt, MD, Odense University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Bleeding; Platelet indices; Platelet aggregometry; Bleeding questionnaire
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Blood Platelet Disorders; Hemorrhage; Thrombocytopenia
• Other Study ID Numbers: s-20120088