LeukemiaNCT02601131
Post-transfusion Platelet Count
An observational study of Leukemia and Multiple Sclerosis, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Multiple Sclerosis
- What is being tested?
- Platelet transfusion
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Clinic of Hematology Diseases, Skåne University Hospital, Lund, Sweden
Who may be able to join
- 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.
Who cannot join
- Patients with aplastic anemia or treatment with antithymocyte globulin (ATG)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Leukemia, Multiple Sclerosis
- Being tested
- Platelet transfusion
- Keywords
- platelet count, platelet transfusion, complement factors, endothelial markers, stem cell transplantation
- Medical subject headings
- Leukemia, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet transfusionBiological
| Study group | Role | What they receive |
|---|---|---|
| AML, ALL and MDS | Patients receiving intensive chemotherapy with diagnoses of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) or myelodysplastic syndromes (MDS). Receives: Biological: Platelet transfusion | |
| Autologous stem cell transplantation | Patients undergoing autologous stem cell transplantation Receives: Biological: Platelet transfusion | |
| Allogeneic stem cell transplantation | Patients undergoing allogeneic stem cell transplantation including both myeloablative conditioning (MAC) and the reduced-intensity conditioning (RIC) Receives: 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 Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in platelet count after platelet transfusion
Measured: 4 days after platelet transfusion
Secondary outcomes (4)
Change in concentrations of complement factors in plasma after platelet transfusion
Measured: 4 days after platelet transfusion
Change in concentrations of endothelial markers in plasma after platelet transfusion
Measured: 4 days after platelet transfusion
Change in concentrations of complement factors in platelet rich plasma after platelet transfusion
Measured: 4 days after platelet transfusion
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
Measured: 4 days after platelet transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kander, Region Skane
- Investigators
- Thomas Kander, MD, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601131
- Sponsor's protocol ID
- Post-transf-PLC
- Status last verified
- Nov 2016
- First submitted
- 28 Oct 2015
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9694735Akesson 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.
PubMed 34210243
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-transfusion Platelet Count
- ClinicalTrials.gov ID
- NCT02601131
- Acronym / sponsor ID
- Post-transf-PLC
- Conditions
- Leukemia, Multiple Sclerosis
- Keywords
- platelet count, platelet transfusion, complement factors, endothelial markers, stem cell transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AML, ALL and MDS | – | Biological: Platelet transfusionPatients receiving intensive chemotherapy with diagnoses of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) or myelodysplastic syndromes (MDS). |
| Autologous stem cell transplantation | – | Biological: Platelet transfusionPatients undergoing autologous stem cell transplantation |
| Allogeneic stem cell transplantation | – | Biological: Platelet transfusionPatients undergoing allogeneic stem cell transplantation including both myeloablative conditioning (MAC) and the reduced-intensity conditioning (RIC) |
| Platelet transfusion prophylaxis | – | Biological: Platelet transfusionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Clinic of Hematology Diseases, Skåne University Hospital, Lund, Sweden
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with aplastic anemia or treatment with antithymocyte globulin (ATG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet transfusion | Biological | AML, ALL and MDS, Allogeneic stem cell transplantation, Autologous stem cell transplantation, Platelet transfusion prophylaxis |
Primary outcome
Change in platelet count after platelet transfusion
Time frame: 4 days after platelet transfusion
4 secondary outcomes
Change in concentrations of complement factors in plasma after platelet transfusion
Time frame: 4 days after platelet transfusion
Change in concentrations of endothelial markers in plasma after platelet transfusion
Time frame: 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
Analysis of platelets in platelet transfusions given to patients included in the study
Time frame: 4 days after platelet transfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Background: PubMed 9694735Norol 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.
- Derived from this study: PubMed 34210243Akesson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kander, MD, PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Multiple Sclerosis, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in platelet count after platelet transfusion (time frame: 4 days after platelet transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02601131, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.