Leukemia, Myeloid, AcuteNCT01976442
Use of Saline-Washed Platelet and Red Cell Transfusions in Adult Acute Leukemia
An observational study of Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Nov 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population is comprised of 98 men and women who were both diagnosed and treated for Acute Myeloid Leukemia or Acute Lymphoid Leukemia at Strong Memorial Hospital, a tertiary medical center located in Rochester, NY, USA. All of these patients received washed red cell and platelet transfusions as part of the hospital's standard protocol for patients with acute leukemia.
Who may be able to join
- previously untreated patients with a diagnosis of acute leukemia between the ages of 0 and 50 (AML) and 18 and 50 (ALL)
Who cannot join
- all other patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Strong Memorial Hospital (University of Rochester Medical Center)
Rochester, New York, 14642
About this study
Official title: Impact of Washed Transfusions in Adult Patients With Acute Myeloid or Lymphoid Leukemia
The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature.
Read the detailed description
The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature. Key outcomes will be treatment related mortality (deaths at 30, 60 and 100 days) and three year survival.
- Keywords
- Leukemia, Transfusion
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Survial Rate at 30 Days
The percentage of patients who were alive at 30 days after transfusion.
Measured: 30 days
Survial Rate at 60 Days
The percentage of patients who were alive at 60 days after transfusion.
Measured: 60 days
Survial Rate at 100 Days
The percentage of patients who were alive at 100 days after transfusion.
Measured: 100 days
Survial Rate at 5 Years
The percentage of patients who were alive at 5 years after transfusion.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startMar 2011
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Blumberg, University of Rochester
- Investigators
- Neil Blumberg, M.D., Principal investigator, University of Rochester Medical Center, School of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976442
- Sponsor's protocol ID
- URMC RSRB00035034
- Status last verified
- Apr 2017
- First submitted
- 16 Oct 2013
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Blumberg N, Heal JM, Rowe JM. A randomized trial of washed red blood cell and platelet transfusions in adult acute leukemia [ISRCTN76536440]. BMC Blood Disord. 2004 Dec 10;4(1):6. doi: 10.1186/1471-2326-4-6.
PubMed 15588315
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Washed Transfusions in Adult Patients With Acute Myeloid or Lymphoid Leukemia
- ClinicalTrials.gov ID
- NCT01976442
- Acronym / sponsor ID
- URMC RSRB00035034
- Keywords
- Leukemia, Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Posted 11 Apr 2017
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 determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature.
Detailed description
The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature. Key outcomes will be treatment related mortality (deaths at 30, 60 and 100 days) and three year survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population is comprised of 98 men and women who were both diagnosed and treated for Acute Myeloid Leukemia or Acute Lymphoid Leukemia at Strong Memorial Hospital, a tertiary medical center located in Rochester, NY, USA. All of these patients received washed red cell and platelet transfusions as part of the hospital's standard protocol for patients with acute leukemia.
Key inclusion criteria (1 listed)
- previously untreated patients with a diagnosis of acute leukemia between the ages of 0 and 50 (AML) and 18 and 50 (ALL)
Key exclusion criteria (1 listed)
- all other patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survial Rate at 30 Days
Time frame: 30 days
The percentage of patients who were alive at 30 days after transfusion.
Survial Rate at 60 Days
Time frame: 60 days
The percentage of patients who were alive at 60 days after transfusion.
Survial Rate at 100 Days
Time frame: 100 days
The percentage of patients who were alive at 100 days after transfusion.
Survial Rate at 5 Years
Time frame: 5 years
The percentage of patients who were alive at 5 years after transfusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15588315Blumberg N, Heal JM, Rowe JM. A randomized trial of washed red blood cell and platelet transfusions in adult acute leukemia [ISRCTN76536440]. BMC Blood Disord. 2004 Dec 10;4(1):6. doi: 10.1186/1471-2326-4-6.
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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.
Neil Blumberg, M.D. principal investigator
University of Rochester Medical Center, School of Medicine and Dentistry
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, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, run by University of Rochester at 1 site in United States.
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 11 Apr 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survial Rate at 30 Days (time frame: 30 days). The study lists 4 primary outcomes in all. 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 NCT01976442, which also lists 1 linked publication.
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 11 Apr 2017.