Post-transfusion Platelet Count

NCT02601131 | Completed

• 1 other identifier: Post-transf-PLC
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Multiple Sclerosis

Keywords

platelet count; platelet transfusion; complement factors; endothelial markers; stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Change in platelet count after platelet transfusion

  4 days after platelet transfusion

Secondary Outcomes (4)

• Change in concentrations of complement factors in 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

• Change in concentrations of complement factors in platelet rich 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

Study Arms (5)

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.

Interventions

Platelet transfusion BIOLOGICAL

AML, ALL and MDS; Allogeneic stem cell transplantation; Autologous stem cell transplantation; Platelet transfusion prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients with aplastic anemia or treatment with antithymocyte globulin (ATG)

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Region Skåne

Lund, 22185, Sweden

Location

Related Publications (2)

• 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.

  PMID: 9694735 BACKGROUND

• Akesson A, Ljungkvist M, Martin M, Blom AM, Klintman J, Schott U, Zetterberg E, Kander T. Biomarkers of Complement and Platelet Activation are not correlated with the One or Twenty-Four Hours Corrected Count Increments in Prophylactically Platelet Transfused Hematological Patients: a Prospective Cohort Study. Platelets. 2022 Apr 3;33(3):350-359. doi: 10.1080/09537104.2021.1942817. Epub 2021 Jul 2.

  PMID: 34210243 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Pending the analyses of complement factors and endothelial markers plasma is stored in -80 degrees Celcius. All samples are destroyed after analyses.

MeSH Terms

Conditions

Leukemia; Multiple Sclerosis

Interventions

Platelet Transfusion

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Thomas Kander, MD, PhD

  Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 10, 2015
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Locations

SE (1)