Post-transfusion Platelet Count

Completed

• Conditions: Leukemia; Multiple Sclerosis

• Registration Number: NCT02601131
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-10
• Study Start: 2016-02
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in platelet count after platelet transfusion	4 days after platelet transfusion

Secondary Outcome Measures

Name	Time	Method
Change in concentrations of complement factors in platelet rich plasma after platelet transfusion	4 days after platelet transfusion
Change in concentrations of endothelial markers in plasma after platelet transfusion	4 days after platelet transfusion
Analysis of platelets in platelet transfusions given to patients included in the study	4 days after platelet transfusion	Flow cytometry of platelets in platelet transfusions given to patients included in the study
Change in concentrations of complement factors in plasma after platelet transfusion	4 days after platelet transfusion

Trial Locations

Locations (1)

Region Skåne; 🇸🇪 Lund, Sweden