Clinical trial NCT02601131: Post-transfusion Platelet Count
Official title: Post-transfusion Platelet Count
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Multiple Sclerosis
Keywords: platelet count
platelet transfusion
complement factors
endothelial markers
stem cell transplantation
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Clinic of Hematology Diseases, Skåne University Hospital, Lund, Sweden

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change in platelet count after platelet transfusion
timeFrame: 4 days after platelet transfusion
Secondary outcomes:
measure: Change in concentrations of complement factors in plasma after platelet transfusion
timeFrame: 4 days after platelet transfusion
measure: Change in concentrations of endothelial markers in plasma after platelet transfusion
timeFrame: 4 days after platelet transfusion
measure: Change in concentrations of complement factors in platelet rich plasma after platelet transfusion
timeFrame: 4 days after platelet transfusion
measure: Analysis of platelets in platelet transfusions given to patients included in the study
timeFrame: 4 days after platelet transfusion
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Region Skåne
Study officials:
affiliation: Region Skåne
name: Thomas Kander, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norol F, Bierling P, Roudot-Thoraval F, Le Coeur FF, Rieux C, Lavaux A, Kuentz M, Duedari N. Platelet transfusion: a dose-response study. Blood. 1998 Aug 15;92(4):1448-53.
citation: Akesson A, Ljungkvist M, Martin M, Blom AM, Klintman J, Schott U, Zetterberg E, Kander T. Biomarkers of Complement and Platelet Activation are not correlated with the One or Twenty-Four Hours Corrected Count Increments in Prophylactically Platelet Transfused Hematological Patients: a Prospective Cohort Study. Platelets. 2022 Apr 3;33(3):350-359. doi: 10.1080/09537104.2021.1942817. Epub 2021 Jul 2.