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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928017
• Other study ID #: 2011/1881
• Status: Completed
• Phase: N/A
• First received: August 16, 2013
• Last updated: December 2, 2014
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Lymphoma
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reticulated platelets percent	To investigate the effect of platelet transfusions on percent reticulated platelets.	1 year	No
Other	Bleeding	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.	1 year	No
Primary	MA	To characterise changes in the TEG-parameter MA in patients with chemotherapy-induced thrombocytopenia	1 year	No