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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01928017
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : December 3, 2014
Haukeland University Hospital
Information provided by (Responsible Party):
Elin Netland Opheim, University of Bergen

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.

Condition or disease
Bone Marrow Diseases Lymphoma

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.

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Study Type : Observational
Actual Enrollment : 13 participants
Time Perspective: Prospective
Official Title: Monitoring of Thromboelastography, Platelet Function and Platelet Recovery in Haemato-oncologic Patients With Thrombocytopenia
Study Start Date : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Hematooncology patients
No intervention

Primary Outcome Measures :
  1. MA [ Time Frame: 1 year ]
    To characterise changes in the TEG-parameter MA in patients with chemotherapy-induced thrombocytopenia

Other Outcome Measures:
  1. Reticulated platelets percent [ Time Frame: 1 year ]
    To investigate the effect of platelet transfusions on percent reticulated platelets.

  2. 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.

Biospecimen Retention:   Samples Without DNA
Plasma specimens are kept frozen.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01928017

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Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
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Study Director: Tor A Hervig, University of Bergen
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Responsible Party: Elin Netland Opheim, Research fellow, University of Bergen Identifier: NCT01928017    
Other Study ID Numbers: 2011/1881
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Bone Marrow Diseases
Blood Platelet Disorders
Hematologic Diseases