Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128713
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2005-08-08
Brief Title:
Optimal Platelet Dose Strategy for Management of Thrombocytopenia
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients A TMH CTN Study
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLADO
Brief 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 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 sites 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 bleedingthrombocytopenic 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
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 sites 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 bleedingthrombocytopenic 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 patients body surface area BSA The dose targets are as follows 1 the lower dose is 11 x 1011m² 2 the medium dose is 22 x 1011m² and 3 the higher dose is 44 x 1011m² 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 patients morning platelet count will be taken every day If this value is less than or equal to 10000 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 eg 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 0017 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 institutions 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
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 patients body surface area BSA The dose targets are as follows 1 the lower dose is 11 x 1011m² 2 the medium dose is 22 x 1011m² and 3 the higher dose is 44 x 1011m² 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 patients morning platelet count will be taken every day If this value is less than or equal to 10000 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 eg 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 0017 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 institutions 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL072359 | NIH | None | httpsreporternihgovquickSearchU01HL072359 |
| U01HL072268 | NIH | None | None |
| U01HL072028 | NIH | None | None |
| U01HL072033 | NIH | None | None |
| U01HL072072 | NIH | None | None |
| U01HL072191 | NIH | None | None |
| U01HL072196 | NIH | None | None |
| U01HL072248 | NIH | None | None |
| U01HL072274 | NIH | None | None |
| U01HL072283 | NIH | None | None |
| U01HL072289 | NIH | None | None |
| U01HL072290 | NIH | None | None |
| U01HL072291 | NIH | None | None |
| U01HL072305 | NIH | None | None |
| U01HL072331 | NIH | None | None |
| U01HL072346 | NIH | None | None |
| U01HL072355 | NIH | None | None |