NCT02306044

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

November 24, 2014

Last Update Submit

August 26, 2019

Conditions

Thrombocytopenia

Keywords

BleedingPlatelet indicesPlatelet aggregometryBleeding questionnaire

Outcome Measures

Primary Outcomes (1)

  • Mean platelet volume

    Mean platelet volume (femtolitre (fL))

    30 days

Secondary Outcomes (4)

  • Platelet count

    30 days

  • immature platelet fraction

    30 days

  • Bleeding questionnaire

    30 days

  • Platelet aggregation

    30 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Admitted patients with thrombocytopenia of any cause

You may qualify if:

  • Admitted patients with thrombocytopenia
  • Age ≥18 years
  • Platelet count below 80 x109/L

You may not qualify if:

  • Platelet transfusion within the previous 14 days,
  • surgery or trauma within the previous 7 days
  • Unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

ThrombocytopeniaHemorrhage

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pernille J Vinholt, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 3, 2014

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 28, 2019

Record last verified: 2019-08