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Post-transfusion Platelet Count

NCT ID: NCT02601131

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Leukemia Multiple Sclerosis

Keywords

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platelet count platelet transfusion complement factors endothelial markers stem cell transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AML, ALL and MDS

Patients receiving intensive chemotherapy with diagnoses of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) or myelodysplastic syndromes (MDS).

Platelet transfusion

Intervention Type BIOLOGICAL

Autologous stem cell transplantation

Patients undergoing autologous stem cell transplantation

Platelet transfusion

Intervention Type BIOLOGICAL

Allogeneic stem cell transplantation

Patients undergoing allogeneic stem cell transplantation including both myeloablative conditioning (MAC) and the reduced-intensity conditioning (RIC)

Platelet transfusion

Intervention Type BIOLOGICAL

Platelet transfusion prophylaxis

Patients receiving platelet transfusion prophylaxis before the intervention, such as insertion of a central venous catheter or lumbar puncture

Platelet transfusion

Intervention Type BIOLOGICAL

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.

No interventions assigned to this group

Interventions

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Platelet transfusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Thomas Kander

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Kander, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skåne

Locations

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Region Skåne

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 9694735 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34210243 (View on PubMed)

Other Identifiers

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Post-transf-PLC

Identifier Type: -

Identifier Source: org_study_id