Clinical Trials Directory

Trials / Completed

CompletedNCT02601131

Post-transfusion Platelet Count

Status
Completed
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
Region Skane · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPlatelet transfusion

Timeline

Start date
2016-02-01
Primary completion
2016-09-01
Completion
2016-09-01
First posted
2015-11-10
Last updated
2016-11-29

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02601131. Inclusion in this directory is not an endorsement.