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Post-transfusion Platelet Count

Post-transfusion Platelet Count

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02601131
Enrollment
80
Registered
2015-11-10
Start date
2016-02-29
Completion date
2016-09-30
Last updated
2016-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Multiple Sclerosis

Keywords

platelet count, platelet transfusion, complement factors, endothelial markers, stem cell transplantation

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.

Interventions

BIOLOGICALPlatelet transfusion

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Change in platelet count after platelet transfusion4 days after platelet transfusion

Secondary

MeasureTime frameDescription
Change in concentrations of complement factors in plasma after platelet transfusion4 days after platelet transfusion
Change in concentrations of endothelial markers in plasma after platelet transfusion4 days after platelet transfusion
Change in concentrations of complement factors in platelet rich plasma after platelet transfusion4 days after platelet transfusion
Analysis of platelets in platelet transfusions given to patients included in the study4 days after platelet transfusionFlow cytometry of platelets in platelet transfusions given to patients included in the study

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026