| Registry | NCT02601131 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 80 (Actual) |
| Sponsor | Region Skane (Other) |
| Conditions | Leukemia, Multiple Sclerosis |
| Interventions | Platelet transfusion (Biological) |
| Dates | start 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 in Sweden |
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All trials for Leukemia All trials for Multiple Sclerosis All trials of Platelet transfusion
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| AML, ALL and MDS | Biological: Platelet transfusion | Patients receiving intensive chemotherapy with diagnoses of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) or myelodysplastic syndromes (MDS). | |
| Autologous stem cell transplantation | Biological: Platelet transfusion | Patients undergoing autologous stem cell transplantation | |
| Allogeneic stem cell transplantation | Biological: Platelet transfusion | Patients undergoing allogeneic stem cell transplantation including both myeloablative conditioning (MAC) and the reduced-intensity conditioning (RIC) | |
| Platelet transfusion prophylaxis | Biological: Platelet transfusion | Patients receiving platelet transfusion prophylaxis before the intervention, such as insertion of a central venous catheter or lumbar puncture | |
| 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. |
Sex: All, ages: 18 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Region Skåne | Lund | Sweden |