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Completed

NCT Number: NCT02601131

Post-transfusion Platelet Count

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Platelet Transfusion

Biological

Primary outcomes

  1. Change in platelet count after platelet transfusion

    Time frame: 4 days after platelet transfusion

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 10, 2015
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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