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
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: August 20, 2013
Last verified: August 2013
  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 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.


Condition
Bone Marrow Diseases
Lymphoma

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)
Groups/Cohorts
Hematooncology patients
No intervention

  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 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 ClinicalTrials.gov identifier: NCT01928017

Contacts
Contact: Elin N Opheim, cand.med. 004755973044 elin.opheim@k2.uib.no
Contact: Tor A Hervig, dr.med 004755972492 tor.hervig@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Elin N Opheim, cand.med    004755973044    elin.opheim@k2.uib.no   
Contact: Torunn O Apelseth, dr. med    004755973092    torunn.oveland.apelseth@helse-bergen.no   
Principal Investigator: Elin N Opheim, cand.med         
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: August 20, 2013
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Bone Marrow Diseases
Lymphoma
Thrombocytopenia
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blood Platelet Disorders

ClinicalTrials.gov processed this record on July 22, 2014