Thromboelastography, Platelet Function and Platelet Recovery in Haemato-oncologic Patients With Thrombocytopenia

December 2, 2014 updated by: Elin Netland Opheim, University of Bergen

Monitoring of Thromboelastography, Platelet Function and Platelet Recovery in Haemato-oncologic Patients With Thrombocytopenia

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Thrombocytopenic patients are followed with blood samples (thromboelastography, Multiplate, haematology) daily, Monday to Friday for up to 30 days.

In addition bleeding evaluation is done daily ,using a standardized questionnaire. The questionnaire is filled out after interview of the patient, and som times next of kin and nurses. Nurse journals and medical journals are also used to fill in the questionnaires.

For thromboelastography (TEG) we are looking at which parameters are abnormal, and if there is other factors than platelet count that influence the results. We will also compare TEG from days with and without bleeding, to see if they differ.

For Multiplate we are doing a pilot study to see whether this analysis can be of any use at all in this group of patients. We are looking into which factors that influence the Multiplate result, and if we can see a difference in the results if the patient is bleeding.

For reticulated platelets and thrombopoietin we are studying the levels related to platelet transfusions.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Bergen, Norway, 5021
    - Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Hematooncology patients No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MA Time Frame: 1 year	To characterise changes in the TEG-parameter MA in patients with chemotherapy-induced thrombocytopenia	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reticulated platelets percent Time Frame: 1 year	To investigate the effect of platelet transfusions on percent reticulated platelets.	1 year
Bleeding Time Frame: 1 year	To investigate the relationship between TEG-parameters, bleeding and need for platelet transfusion. To investigate the influence of HLA antibodies on risk of bleeding and transfusion complications.	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Haukeland University Hospital

Investigators

Study Director: Tor A Hervig, dr.med, University of Bergen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 16, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (Estimate)

August 23, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

2011/1881

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.