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

This study has been completed.
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Elin Netland Opheim, University of Bergen
ClinicalTrials.gov Identifier:
NCT01928017
First received: August 16, 2013
Last updated: December 2, 2014
Last verified: December 2014

August 16, 2013
December 2, 2014
June 2013
June 2014   (final data collection date for primary outcome measure)
MA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To characterise changes in the TEG-parameter MA in patients with chemotherapy-induced thrombocytopenia
Thromboelastography [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To characterise changes in TEG-parameters in patients with chemotherapy-induced thrombocytopenia
Complete list of historical versions of study NCT01928017 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Reticulated platelets percent [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To investigate the effect of platelet transfusions on percent reticulated platelets.
  • Bleeding [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.

  • Cytokines [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To investigate cytokine profiles in patients with and without bleeding with the aim of identifying risk factors of bleeding in patients with chemotherapy-induced thrombocytopenia
  • Bleeding [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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.

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

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma specimens are kept frozen.

Non-Probability Sample

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.

  • Bone Marrow Diseases
  • Lymphoma
Not Provided
Hematooncology patients
No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
June 2014
June 2014   (final data collection date for primary outcome measure)

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

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01928017
2011/1881
No
Elin Netland Opheim, University of Bergen
University of Bergen
Haukeland University Hospital
Study Director: Tor A Hervig, dr.med University of Bergen
University of Bergen
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP