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
  Purpose

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
Bone Marrow Diseases
Lymphoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Monitoring of Thromboelastography, Platelet Function and Platelet Recovery in Haemato-oncologic Patients With Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • MA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To characterise changes in the TEG-parameter MA in patients with chemotherapy-induced thrombocytopenia


Other Outcome Measures:
  • 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.



Biospecimen Retention:   Samples Without DNA

Plasma specimens are kept frozen.


Enrollment: 13
Study Start Date: June 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hematooncology patients
No intervention

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928017

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
Study Director: Tor A Hervig, dr.med University of Bergen
  More Information

No publications provided

Responsible Party: Elin Netland Opheim, Research fellow, University of Bergen
ClinicalTrials.gov Identifier: NCT01928017     History of Changes
Other Study ID Numbers: 2011/1881
Study First Received: August 16, 2013
Last Updated: December 2, 2014
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Bone Marrow Diseases
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on April 23, 2015