Post-transfusion Platelet Count

Multiple Sclerosis Clinical Trial

Official title:

Post-transfusion Platelet Count

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601131
• Other study ID #: Post-transf-PLC
• Status: Completed
• Phase: N/A
• First received: October 28, 2015
• Last updated: November 28, 2016
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Multiple Sclerosis

Intervention

Biological:
• Platelet transfusion

Locations

Country	Name	City	State
Sweden	Region Skåne	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in platelet count after platelet transfusion		4 days after platelet transfusion	No
Secondary	Change in concentrations of complement factors in plasma after platelet transfusion		4 days after platelet transfusion	No
Secondary	Change in concentrations of endothelial markers in plasma after platelet transfusion		4 days after platelet transfusion	No
Secondary	Change in concentrations of complement factors in platelet rich plasma after platelet transfusion		4 days after platelet transfusion	No
Secondary	Analysis of platelets in platelet transfusions given to patients included in the study	Flow cytometry of platelets in platelet transfusions given to patients included in the study	4 days after platelet transfusion	No