Post-transfusion Platelet Count

November 28, 2016 updated by: Thomas Kander, Region Skane
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22185
        • Region Skane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to the Clinic of Hematology Diseases, Skåne University Hospital, Lund, Sweden

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AML, ALL and MDS
Patients receiving intensive chemotherapy with diagnoses of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) or myelodysplastic syndromes (MDS).
Biological: Platelet transfusion
Autologous stem cell transplantation
Patients undergoing autologous stem cell transplantation
Biological: Platelet transfusion
Allogeneic stem cell transplantation
Patients undergoing allogeneic stem cell transplantation including both myeloablative conditioning (MAC) and the reduced-intensity conditioning (RIC)
Biological: Platelet transfusion
Platelet transfusion prophylaxis
Patients receiving platelet transfusion prophylaxis before the intervention, such as insertion of a central venous catheter or lumbar puncture
Biological: Platelet transfusion
Control
Patients with AML, ALL or MDS that have low PLC (10-20 billion/L) and is not relevant for platelet transfusion. Samples taken in the same manner as in the other groups. Control is needed to rule out other causes of variation of the PLC than the platelet transfusion and thereby strengthen the causality between a given transfusion and increased PLC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in platelet count after platelet transfusion
Time Frame: 4 days after platelet transfusion
4 days after platelet transfusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in concentrations of complement factors in plasma after platelet transfusion
Time Frame: 4 days after platelet transfusion
4 days after platelet transfusion
Change in concentrations of endothelial markers in plasma after platelet transfusion
Time Frame: 4 days after platelet transfusion
4 days after platelet transfusion
Change in concentrations of complement factors in platelet rich plasma after platelet transfusion
Time Frame: 4 days after platelet transfusion
4 days after platelet transfusion
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
4 days after platelet transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Thomas Kander, MD, PhD, Region Skane

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Post-transf-PLC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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