ThrombocytopeniaPhase 3PLADONCT00128713
Optimal Platelet Dose Strategy for Management of Thrombocytopenia
A Phase 3 study testing Medium Dose Prophylactic Platelet Transfusions, Lower Dose Prophylactic Platelet Transfusions and Higher Dose Prophylactic Platelet Transfusions in people with Thrombocytopenia, run by Carelon Research at 21 sites in United States.
Trial summary
The primary objective of this study is to compare the three study arms of lower, medium, and higher dose platelet therapy with respect to the percentage of patients experiencing at least one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding Scale (Grade 2 bleeding corresponds to… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Medium Dose Prophylactic Platelet Transfusions, Lower Dose Prophylactic Platelet Transfusions and Higher Dose Prophylactic Platelet Transfusions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,351 participants
- Where
- 21 sitesUnited States
- Study dates
- Jul 2004to Jan 2008
- Phase
- Phase 3
- 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 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has, or is expected to have, hypoproliferative thrombocytopenia, and is expected to have a platelet count of up to 10,000 ul for at least 5 days and be in the hospital for at least 5 days
- Weight is between 10 and 135 kilograms
- PT/INR, PTT, and fibrinogen assays that are measured within 72 hours before study entry are as follows:
- PT less than or equal to 1.3 times the upper limit of normal for the laboratory
- PTT less than or equal to 1.3 times the upper limit of normal for the laboratory
- Fibrinogen greater than or equal to 100 mg/dl
- Undergoing, or has completed, hematopoietic stem cell transplantation, for any diagnosis; OR has a diagnosis of acute or chronic leukemia, non-Hodgkins or Hodgkins lymphoma, myeloma, myelodysplasia, or non-hematologic malignancy and is undergoing, or has completed, chemotherapy
- During this hospitalization, the patient has not yet received any platelet transfusions related to the current or planned course of therapy (individual platelet transfusions given prior to the study and unrelated to thrombocytopenia will not exclude the patient)
Who cannot join
- Evidence of greater than or equal to Grade 2 bleeding (as determined by the Platelet Dose Trial Bleeding Scale)
- Receiving antithrombotic drugs
- Will receive bedside leuko-reduced platelet transfusions
- Present, or history of, platelet transfusion refractoriness within 30 days prior to study entry
- Pre-enrollment lymphocytotoxic antibody screen (PRA) known to be greater than or equal to 20% based on prior data
- Present, or history of, acute promyelocytic leukemia (APML), immune thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic-uremic syndrome (HUS)
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- Will be transfused at platelet trigger of greater than 10,000 platelets/ul
- Recent history of major surgery (within 2 weeks of study entry)
- Currently taking, or participating in a study involving, platelet substitutes, platelet growth factors, or pharmacologic agents intended to enhance or decrease platelet hemostatic function
- Pregnant
- Previously enrolled in this study
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Emory University Hospitals; Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Children's Hospital Boston; Beth Israel Deaconess Medical Center; Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514
University Hospital Cleveland
Cleveland, Ohio, 44106
U of Texas SW Medical Center at Dallas
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53201
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
Oncology Alliance/St. Luke's Hospital
Milwaukee, Wisconsin, 53215
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
Tulane University Hospital and Clinics
New Orleans, Louisiana, 70112
NY-Presbyterian Hosp/Weill Cornell Medical Center
New York, New York, 10021
U of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
U of Pennsylvania Health System; Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Presbyterian and Shadyside Hospital
Pittsburgh, Pennsylvania, 15213
Virginia Mason Hospital
Seattle, Washington, 98101
U of Washington Medical Center/FHCRC; Children's Hospital and Medical Center
Seattle, Washington, 98104
About this study
Official title: Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients (A TMH CTN Study)
The primary objective of this study is to compare the three study arms of lower, medium, and higher dose platelet therapy with respect to the percentage of patients experiencing at least one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding Scale (Grade 2 bleeding corresponds to bleeding that is moderate, but not severe enough to warrant red blood cell transfusion).
There are a number of secondary endpoints related to platelet transfusions, hemostasis, and other concerns. The four most important secondary endpoints will compare the three study arms with respect to the following outcomes: 1) platelet utilization rates (total number of platelets transfused x 10 ^11); 2) number of platelet transfusion events (frequency of transfusions); a transfusion event would be defined as each separate platelet transfusion issued by the study site's transfusion service; 3) highest category of bleeding during time of study (Platelet Dose Trial Bleeding Scale Grades less than or equal to 1, 2, 3, or 4 by arm); and 4) bleeding severity based on number of days with bleeding (total days of bleeding and bleeding/thrombocytopenic day), intensity of bleeding, and number of sites with bleeding (if such a severity score has been validated and published by the time the study is completed).
Read the detailed description
BACKGROUND:
It is important to identify the safest and most cost effective strategies for providing platelet support that will achieve effective disease management without depleting platelet supplies. Informative clinical data have been provided concerning the platelet transfusion trigger. In contrast, the optimal quantity of platelets to be used per transfusion remains a highly controversial subject. No prospective platelet transfusion studies have been performed in which patients are randomized to an assigned platelet dose throughout their period of thrombocytopenia.
DESIGN NARRATIVE:
After obtaining consent and verifying eligibility requirements, the patients will be randomized to one of three doses for prophylactic platelet transfusions (lower, medium, or higher dose). The dosage is based on the patient's body surface area (BSA). The dose targets are as follows: 1) the lower dose is 1.1 x 10^11/m²; 2) the medium dose is 2.2 x 10^11/m²; and 3) the higher dose is 4.4 x 10^11/m². A dose within 25% of this value in either direction is considered to be in the target range. For many adult patients, the typical dose of one unit of apheresis platelets would fall in the target range for the medium dose. All prophylactic transfusions provided while the patient is in the study will be given according to the randomized target dose range. Only blood bank staff, not clinical staff, will have access to the target dose range for each patient.
The patient's morning platelet count will be taken every day. If this value is less than or equal to 10,000, a prophylactic platelet transfusion will be given. Otherwise, no prophylactic platelet transfusion will be given that day. Platelet transfusions may be given at any time, and at any dose, to treat active bleeding or in association with an invasive procedure. A hemostatic assessment will be carried out every day to identify any bleeding the patient may experience. This assessment involves a patient interview, physical assessment, and a chart review. Data on all transfusions (e.g., platelets and red blood cells), all transfusion-related events, all serious adverse events, and protocol deviations will also be recorded.
Patients will participate in the study either until 30 days after the initial platelet transfusion, until they have not received a platelet transfusion for 10 days after the most recent platelet transfusion, or until hospital discharge (whichever comes first).
Each of the three pairwise dose comparisons is of interest. Therefore, the primary and secondary endpoints will be analyzed using three separate pairwise comparisons, each at the 0.017 significance level to adjust for multiple comparisons.
This study has been approved by the National Heart, Lung, and Blood Institute (NHLBI)-appointed protocol review committee and data and safety monitoring board (DSMB), and each participating institution's institutional review board. An interim monitoring plan was developed by the protocol team and DSMB, and is described in the protocol. The study is being monitored in accordance with this plan.
- Conditions
- Thrombocytopenia
- Being tested
- Medium Dose Prophylactic Platelet Transfusions, Lower Dose Prophylactic Platelet Transfusions, Higher Dose Prophylactic Platelet Transfusions
- Keywords
- Blood Transfusion, Blood Platelets
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium Dose Prophylactic Platelet TransfusionsProcedure or surgery
2.2 x 10^11 platelets per m^2 BSA
Lower Dose Prophylactic Platelet TransfusionsProcedure or surgery
1.1 x 10^11 platelets per m^2 BSA
Higher Dose Prophylactic Platelet TransfusionsProcedure or surgery
4.4 * 10^11 platelets per m^2 BSA
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lower Dose Prophylactic Platelets Receives: Procedure: Lower Dose Prophylactic Platelet Transfusions |
| 2 | Active comparator | Medium Dose Prophylactic Platelets Receives: Procedure: Medium Dose Prophylactic Platelet Transfusions |
| 3 | Active comparator | Higher Dose Prophylactic Platelets Receives: Procedure: Higher Dose Prophylactic Platelet Transfusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
At Least One Day With Grade 2 or Higher Bleeding
Any Grade 2 (moderate) or higher grade bleeding, as determined by daily hemostatic assessment and documentation of any red blood cell transfusions to treat bleeding
Measured: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Secondary outcomes (4)
Platelet Utilization
Total number of platelets transfused, based on attempted dose, among subjects who have at least one platelet transfusion and no missing data on attempted doses.
Measured: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Number of Platelet Transfusion Episodes
Number of platelet transfusion episodes among subjects who have at least one platelet transfusion and no missing data on attempted doses.
Measured: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Bleeding Severity, if a Suitable Scale is Validated and Published by the Time the Trial Ends
No suitable scale was identified, so no analyses for this outcome were carried out
Measured: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Highest Grade of Bleeding While on Study
Highest grade of bleeding during time on study using Platelet Dose Trial modification of World Health Organization Bleeding Scale. Grades 0-1 (no or minimal bleeding), 2 (moderate bleeding), 3 (bleeding generally requiring red cell transfusion), 4 (severe bleeding)
Measured: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionJan 2008
- Study completionJan 2008
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 (4)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Transfusion Medicine/Hemostasis Clinical Research Network
- Responsible party
- Sponsor
- Investigators
- Susan F. Assmann, Principal investigator, New England Research Institutes, Inc.Mark Brecher, MD, Principal investigator, University of North CarolinaJames B. Bussel, MD, Principal investigator, NY-Presbyterian Hosp/Weill Cornell Medical CenterJames George, MD, Principal investigator, U of Oklahoma Health Sciences CenterJohn R. Hess, Principal investigator, University of Maryland, BaltimoreChristopher D. Hillyer, MD, Principal investigator, Emory UniversityBarbara A. Konkle, MD, Principal investigator, University of PennsylvaniaCindy A. Leissinger, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128713
- Sponsor's protocol ID
- 238
- Other IDs
- U01HL072268, U01HL072028, U01HL072033, U01HL072072, U01HL072191, U01HL072196, U01HL072248, U01HL072274
- Acronym
- PLADO
- Status last verified
- Aug 2013
- First submitted
- 8 Aug 2005
- Last updated
- 28 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Uhl L, Assmann SF, Hamza TH, Harrison RW, Gernsheimer T, Slichter SJ. Laboratory predictors of bleeding and the effect of platelet and RBC transfusions on bleeding outcomes in the PLADO trial. Blood. 2017 Sep 7;130(10):1247-1258. doi: 10.1182/blood-2017-01-757930. Epub 2017 Jul 5.
PubMed 28679741Josephson CD, Granger S, Assmann SF, Castillejo MI, Strauss RG, Slichter SJ, Steiner ME, Journeycake JM, Thornburg CD, Bussel J, Grabowski EF, Neufeld EJ, Savage W, Sloan SR. Bleeding risks are higher in children versus adults given prophylactic platelet transfusions for treatment-induced hypoproliferative thrombocytopenia. Blood. 2012 Jul 26;120(4):748-60. doi: 10.1182/blood-2011-11-389569. Epub 2012 Apr 26.
PubMed 22538854Triulzi DJ, Assmann SF, Strauss RG, Ness PM, Hess JR, Kaufman RM, Granger S, Slichter SJ. The impact of platelet transfusion characteristics on posttransfusion platelet increments and clinical bleeding in patients with hypoproliferative thrombocytopenia. Blood. 2012 Jun 7;119(23):5553-62. doi: 10.1182/blood-2011-11-393165. Epub 2012 Apr 10.
PubMed 22496156Slichter SJ, Kaufman RM, Assmann SF, McCullough J, Triulzi DJ, Strauss RG, Gernsheimer TB, Ness PM, Brecher ME, Josephson CD, Konkle BA, Woodson RD, Ortel TL, Hillyer CD, Skerrett DL, McCrae KR, Sloan SR, Uhl L, George JN, Aquino VM, Manno CS, McFarland JG, Hess JR, Leissinger C, Granger S. Dose of prophylactic platelet transfusions and prevention of hemorrhage. N Engl J Med. 2010 Feb 18;362(7):600-13. doi: 10.1056/NEJMoa0904084.
PubMed 20164484
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients (A TMH CTN Study)
- ClinicalTrials.gov ID
- NCT00128713
- Acronym / sponsor ID
- PLADO / 238
- Conditions
- Thrombocytopenia
- Keywords
- Blood Transfusion, Blood Platelets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,351 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Transfusion Medicine/Hemostasis Clinical Research Network
- Study start
- Jul 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Aug 2005 (estimated)
- Results
- Posted 16 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the three study arms of lower, medium, and higher dose platelet therapy with respect to the percentage of patients experiencing at least one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding Scale (Grade 2 bleeding corresponds to bleeding that is moderate, but not severe enough to warrant red blood cell transfusion).
There are a number of secondary endpoints related to platelet transfusions, hemostasis, and other concerns. The four most important secondary endpoints will compare the three study arms with respect to the following outcomes: 1) platelet utilization rates (total number of platelets transfused x 10 ^11); 2) number of platelet transfusion events (frequency of transfusions); a transfusion event would be defined as each separate platelet transfusion issued by the study site's transfusion service; 3) highest category of bleeding during time of study (Platelet Dose Trial Bleeding Scale Grades less than or equal to 1, 2, 3, or 4 by arm); and 4) bleeding severity based on number of days with bleeding (total days of bleeding and bleeding/thrombocytopenic day), intensity of bleeding, and number of sites with bleeding (if such a severity score has been validated and published by the time the study is completed).
Detailed description
BACKGROUND:
It is important to identify the safest and most cost effective strategies for providing platelet support that will achieve effective disease management without depleting platelet supplies. Informative clinical data have been provided concerning the platelet transfusion trigger. In contrast, the optimal quantity of platelets to be used per transfusion remains a highly controversial subject. No prospective platelet transfusion studies have been performed in which patients are randomized to an assigned platelet dose throughout their period of thrombocytopenia.
DESIGN NARRATIVE:
After obtaining consent and verifying eligibility requirements, the patients will be randomized to one of three doses for prophylactic platelet transfusions (lower, medium, or higher dose). The dosage is based on the patient's body surface area (BSA). The dose targets are as follows: 1) the lower dose is 1.1 x 10^11/m²; 2) the medium dose is 2.2 x 10^11/m²; and 3) the higher dose is 4.4 x 10^11/m². A dose within 25% of this value in either direction is considered to be in the target range. For many adult patients, the typical dose of one unit of apheresis platelets would fall in the target range for the medium dose. All prophylactic transfusions provided while the patient is in the study will be given according to the randomized target dose range. Only blood bank staff, not clinical staff, will have access to the target dose range for each patient.
The patient's morning platelet count will be taken every day. If this value is less than or equal to 10,000, a prophylactic platelet transfusion will be given. Otherwise, no prophylactic platelet transfusion will be given that day. Platelet transfusions may be given at any time, and at any dose, to treat active bleeding or in association with an invasive procedure. A hemostatic assessment will be carried out every day to identify any bleeding the patient may experience. This assessment involves a patient interview, physical assessment, and a chart review. Data on all transfusions (e.g., platelets and red blood cells), all transfusion-related events, all serious adverse events, and protocol deviations will also be recorded.
Patients will participate in the study either until 30 days after the initial platelet transfusion, until they have not received a platelet transfusion for 10 days after the most recent platelet transfusion, or until hospital discharge (whichever comes first).
Each of the three pairwise dose comparisons is of interest. Therefore, the primary and secondary endpoints will be analyzed using three separate pairwise comparisons, each at the 0.017 significance level to adjust for multiple comparisons.
This study has been approved by the National Heart, Lung, and Blood Institute (NHLBI)-appointed protocol review committee and data and safety monitoring board (DSMB), and each participating institution's institutional review board. An interim monitoring plan was developed by the protocol team and DSMB, and is described in the protocol. The study is being monitored in accordance with this plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Lower Dose Prophylactic Platelet TransfusionsLower Dose Prophylactic Platelets |
| 2 | Active comparator | Procedure: Medium Dose Prophylactic Platelet TransfusionsMedium Dose Prophylactic Platelets |
| 3 | Active comparator | Procedure: Higher Dose Prophylactic Platelet TransfusionsHigher Dose Prophylactic Platelets |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Has, or is expected to have, hypoproliferative thrombocytopenia, and is expected to have a platelet count of up to 10,000 ul for at least 5 days and be in the hospital for at least 5 days
- Weight is between 10 and 135 kilograms
- PT/INR, PTT, and fibrinogen assays that are measured within 72 hours before study entry are as follows:
- Undergoing, or has completed, hematopoietic stem cell transplantation, for any diagnosis; OR has a diagnosis of acute or chronic leukemia, non-Hodgkins or Hodgkins lymphoma, myeloma, myelodysplasia, or non-hematologic malignancy and is undergoing, or has completed, chemotherapy
- During this hospitalization, the patient has not yet received any platelet transfusions related to the current or planned course of therapy (individual platelet transfusions given prior to the study and unrelated to thrombocytopenia will not exclude the patient)
Key exclusion criteria (11 listed)
- Evidence of greater than or equal to Grade 2 bleeding (as determined by the Platelet Dose Trial Bleeding Scale)
- Receiving antithrombotic drugs
- Will receive bedside leuko-reduced platelet transfusions
- Present, or history of, platelet transfusion refractoriness within 30 days prior to study entry
- Pre-enrollment lymphocytotoxic antibody screen (PRA) known to be greater than or equal to 20% based on prior data
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 |
|---|---|---|
| Medium Dose Prophylactic Platelet Transfusions2.2 x 10^11 platelets per m^2 BSA | Procedure or surgery | 2 |
| Lower Dose Prophylactic Platelet Transfusions1.1 x 10^11 platelets per m^2 BSA | Procedure or surgery | 1 |
| Higher Dose Prophylactic Platelet Transfusions4.4 * 10^11 platelets per m^2 BSA | Procedure or surgery | 3 |
Primary outcome
At Least One Day With Grade 2 or Higher Bleeding
Time frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Any Grade 2 (moderate) or higher grade bleeding, as determined by daily hemostatic assessment and documentation of any red blood cell transfusions to treat bleeding
4 secondary outcomes
Platelet Utilization
Time frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Number of Platelet Transfusion Episodes
Time frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Bleeding Severity, if a Suitable Scale is Validated and Published by the Time the Trial Ends
Time frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Highest Grade of Bleeding While on Study
Time frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28679741Uhl L, Assmann SF, Hamza TH, Harrison RW, Gernsheimer T, Slichter SJ. Laboratory predictors of bleeding and the effect of platelet and RBC transfusions on bleeding outcomes in the PLADO trial. Blood. 2017 Sep 7;130(10):1247-1258. doi: 10.1182/blood-2017-01-757930. Epub 2017 Jul 5.
- Derived from this study: PubMed 22538854Josephson CD, Granger S, Assmann SF, Castillejo MI, Strauss RG, Slichter SJ, Steiner ME, Journeycake JM, Thornburg CD, Bussel J, Grabowski EF, Neufeld EJ, Savage W, Sloan SR. Bleeding risks are higher in children versus adults given prophylactic platelet transfusions for treatment-induced hypoproliferative thrombocytopenia. Blood. 2012 Jul 26;120(4):748-60. doi: 10.1182/blood-2011-11-389569. Epub 2012 Apr 26.
- Derived from this study: PubMed 22496156Triulzi DJ, Assmann SF, Strauss RG, Ness PM, Hess JR, Kaufman RM, Granger S, Slichter SJ. The impact of platelet transfusion characteristics on posttransfusion platelet increments and clinical bleeding in patients with hypoproliferative thrombocytopenia. Blood. 2012 Jun 7;119(23):5553-62. doi: 10.1182/blood-2011-11-393165. Epub 2012 Apr 10.
- Derived from this study: PubMed 20164484Slichter SJ, Kaufman RM, Assmann SF, McCullough J, Triulzi DJ, Strauss RG, Gernsheimer TB, Ness PM, Brecher ME, Josephson CD, Konkle BA, Woodson RD, Ortel TL, Hillyer CD, Skerrett DL, McCrae KR, Sloan SR, Uhl L, George JN, Aquino VM, Manno CS, McFarland JG, Hess JR, Leissinger C, Granger S. Dose of prophylactic platelet transfusions and prevention of hemorrhage. N Engl J Med. 2010 Feb 18;362(7):600-13. doi: 10.1056/NEJMoa0904084.
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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.
Susan F. Assmann principal investigator
New England Research Institutes, Inc.
Mark Brecher, MD principal investigator
University of North Carolina
James B. Bussel, MD principal investigator
NY-Presbyterian Hosp/Weill Cornell Medical Center
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medium Dose Prophylactic Platelet Transfusions, Lower Dose Prophylactic Platelet Transfusions and Higher Dose Prophylactic Platelet Transfusions in people with Thrombocytopenia, run by Carelon Research at 21 sites 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 8 inclusion and 11 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2009). 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?
At Least One Day With Grade 2 or Higher Bleeding (time frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)). 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 NCT00128713, which also lists 4 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 28 Oct 2015.