NCT01928017

Brief Summary

This is a prospective observational clinical study to characterise abnormalities of thromboelastography (TEG) parameters in patients with chemotherapy-induced thrombocytopenia. The investigators are also studying the relationship between Multiplate analysis and bleeding in these patients and the effect of platelet transfusions on thrombopoietin level and percent reticulated platelets. The investigators' hypothesis is that changes in TEG-parameters reflect the patients tendency to bleed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

August 16, 2013

Last Update Submit

December 2, 2014

Conditions

Bone Marrow DiseasesLymphoma

Outcome Measures

Primary Outcomes (1)

  • MA

    To characterise changes in the TEG-parameter MA in patients with chemotherapy-induced thrombocytopenia

    1 year

Other Outcomes (2)

  • Reticulated platelets percent

    1 year

  • Bleeding

    1 year

Study Arms (1)

Hematooncology patients

No intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital inpatients admitted to the Department of Medicine, Section for Haematology at Haukeland University Hospital will be invited to join the study if they meet the inclusion criteria.

You may qualify if:

  • Patients are eligible for this study if:
  • They have a haemato-oncologic disease They have, or are expected to have, thrombocytopenia They are expected to need at least one platelet transfusion They are aged 18 years or over They consent to participate

You may not qualify if:

  • Patients are not eligible for this study if:
  • They have a known congenital clotting disorder They need anticoagulants regularly in the study period They have immune thrombocytopenic purpura

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma specimens are kept frozen.

MeSH Terms

Conditions

Bone Marrow DiseasesLymphoma

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Tor A Hervig, dr.med

    University of Bergen

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

August 16, 2013

First Posted

August 23, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

NO(1)