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Post-transfusion Platelet Count

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ClinicalTrials.gov Identifier: NCT02601131
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Kander, Region Skane

Brief Summary:
The purpose of this study is to identify how the platelet count, complement system and endothelial markers are affected over time, after platelet transfusion in 4 different hematological patient groups.

Condition or disease Intervention/treatment
Leukemia Multiple Sclerosis Biological: Platelet transfusion

Detailed Description:

Patients who are hospitalized at the Clinic for Hematology Diseases at the Skåne University Hospital (SUS) in Lund, Sweden with a central venous catheter or port-a-cath and should receive platelet transfusion due to thrombocytopenia are asked to participate in the study. Some patients who are being considered for platelet transfusions on several occasions will be able to attend more than one time in this study. After signed informed consent blood samples are drawn from the central line before, immediately after and then approximately. 1, 4, 8, 16 and 24 hours following the platelet transfusion. The platelet count (PLC) will then be taken daily following 4 days.

Sample size. Data from previous studies (Norol-98) shows that the PLC after platelet transfusion rises by 33 ± 25 x109/L (mean ± SD) 12 hours post-transfusion in patients with acute myeloid leukemia or pre-conditioning prior to bone marrow transplantation. The investigators want to show the same rise in the PLC after 12 hours with 80% power and 5% alpha risk of error for each group resulting in the sample size 13 per group and a total of 65 patients.


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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-transfusion Platelet Count
Study Start Date : February 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
AML, ALL and MDS
Patients receiving intensive chemotherapy with diagnoses of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) or myelodysplastic syndromes (MDS).
Biological: Platelet transfusion
Autologous stem cell transplantation
Patients undergoing autologous stem cell transplantation
Biological: Platelet transfusion
Allogeneic stem cell transplantation
Patients undergoing allogeneic stem cell transplantation including both myeloablative conditioning (MAC) and the reduced-intensity conditioning (RIC)
Biological: Platelet transfusion
Platelet transfusion prophylaxis
Patients receiving platelet transfusion prophylaxis before the intervention, such as insertion of a central venous catheter or lumbar puncture
Biological: Platelet transfusion
Control
Patients with AML, ALL or MDS that have low PLC (10-20 billion/L) and is not relevant for platelet transfusion. Samples taken in the same manner as in the other groups. Control is needed to rule out other causes of variation of the PLC than the platelet transfusion and thereby strengthen the causality between a given transfusion and increased PLC.



Primary Outcome Measures :
  1. Change in platelet count after platelet transfusion [ Time Frame: 4 days after platelet transfusion ]

Secondary Outcome Measures :
  1. Change in concentrations of complement factors in plasma after platelet transfusion [ Time Frame: 4 days after platelet transfusion ]
  2. Change in concentrations of endothelial markers in plasma after platelet transfusion [ Time Frame: 4 days after platelet transfusion ]
  3. Change in concentrations of complement factors in platelet rich plasma after platelet transfusion [ Time Frame: 4 days after platelet transfusion ]
  4. Analysis of platelets in platelet transfusions given to patients included in the study [ Time Frame: 4 days after platelet transfusion ]
    Flow cytometry of platelets in platelet transfusions given to patients included in the study


Biospecimen Retention:   Samples With DNA
Pending the analyses of complement factors and endothelial markers plasma is stored in -80 degrees Celcius. All samples are destroyed after analyses.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the Clinic of Hematology Diseases, Skåne University Hospital, Lund, Sweden
Criteria

Inclusion Criteria:

  • Patients admitted to the Clinic of Hematology Diseases, Skåne University Hospital, Lund, Sweden belonging to either of the groups described in paragraph 8 above and are prescribed platelet transfusion.

Exclusion Criteria:

  • Patients with aplastic anemia or treatment with antithymocyte globulin (ATG)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601131


Locations
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Sweden
Region Skåne
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Thomas Kander, MD, PhD Region Skåne

Publications:
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Responsible Party: Thomas Kander, MD, PhD, Region Skane
ClinicalTrials.gov Identifier: NCT02601131     History of Changes
Other Study ID Numbers: Post-transf-PLC
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016

Keywords provided by Thomas Kander, Region Skane:
platelet count
platelet transfusion
complement factors
endothelial markers
stem cell transplantation

Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases