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Thromboelastography, Cytokines and HLA-antibodies in Patients With Chemotherapy-induced Thrombocytopenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Bergen
Haukeland University Hospital
Information provided by (Responsible Party):
Elin Netland Opheim, University of Bergen Identifier:
First received: August 16, 2013
Last updated: August 20, 2013
Last verified: August 2013

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 influence of cytokines on bleeding and of HLA-antibodies on effect of platelet transfusion in the patient group mentioned.

The investigators' hypothesis is that changes in TEG-parameters reflect the patients tendency to bleed.

Bone Marrow Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Thromboelastography, Cytokines and HLA-antibodies in Patients With Chemotherapy-induced Thrombocytopenia

Resource links provided by NLM:

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Thromboelastography [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To characterise changes in TEG-parameters in patients with chemotherapy-induced thrombocytopenia

Other Outcome Measures:
  • 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.

Biospecimen Retention:   Samples Without DNA

Plasma specimens are kept frozen.

Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Hematooncology patients
No intervention


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.


Inclusion Criteria:

Patients are eligible for this study if:

  • They have chemotherapy-induced thrombocytopenia
  • They are in need of at least one platelet transfusion
  • They are aged 16 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 identifier: NCT01928017

Contact: Elin N Opheim, 004755973044
Contact: Tor A Hervig, 004755972492

Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Elin N Opheim,    004755973044   
Contact: Torunn O Apelseth, dr. med    004755973092   
Principal Investigator: Elin N Opheim,         
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Study Director: Tor A Hervig, University of Bergen
  More Information

No publications provided

Responsible Party: Elin Netland Opheim, Research fellow, University of Bergen Identifier: NCT01928017     History of Changes
Other Study ID Numbers: 2011/1881
Study First Received: August 16, 2013
Last Updated: August 20, 2013
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Bone Marrow Diseases
Blood Platelet Disorders
Hematologic Diseases processed this record on November 25, 2014