Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599762
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Tranexamic Acid Among Outpatients with Myelodysplastic Syndromes and Acute Myeloid Leukemia a Multicenter Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYELO-CANTXA
Brief Summary:
Myelodysplastic syndromes MDS and acute myeloid leukemia AML are serious life changing blood cancers Patients with MDS and AML commonly experience complications related to bleeding which affect patient quality-of-life and can sometimes lead to hospitalization or death The investigators will conduct a randomized controlled trial to evaluate the effectiveness and safety of tranexamic acid TXA a medication that prevents clots from dissolving to prevent bleeding In this study 50 of patients will be randomized like the flip of a coin to receive TXA the other 50 of patients will receive placebo The investigators will monitor both groups of patients to see if the medication improves the risk andor severity of bleeding If tranexamic acid were to safely reduced the frequency of bleeding this would broadly influence how doctors provide care for patients with MDS and AML around the world
Detailed Description:
RATIONALE Myelodysplastic syndromes MDS and acute myeloid leukemia AML are serious life-changing blood cancers Despite the best efforts of their care team patients with MDS and AML commonly experience complications related to bleeding These complications affect patient quality-of-life and can sometimes lead to hospitalization or death Evaluation of affordable and widely available treatments to minimize bleeding complications among patients with MDS and AML is needed
STUDY OBJECTIVES To evaluate the feasibility of tranexamic acid TXA that will evaluate the efficacy and safety of treatments to minimize bleeding in patients with MDS and AML treated in the outpatient setting
METHODOLOGY The investigators will conduct a multicenter pilot randomized control trial RCT for outpatients 18 years of age with MDS and AML Patients with MDS and AML with low platelet counts will receive TXA a medication that prevents clots from dissolving TXA is commonly used in other clinical settings but have not been studied in patients with MDS or AML receiving outpatient chemotherapy ie chemotherapy that can be given from clinic rather than a hospital In this study 50 of patients will be randomized like the flip of a coin to receive the medication the investigators are studying The other 50 of patients will receive a matching placebo
OUTCOMES The primary feasibility outcome is the ability to enroll a mean of 1 patient per site per month
SITES AND DURATION The investigators will initially enroll patients from 10-15 sites across Canada The expected duration of enrollment is 2 years
SIGNIFICANCE With a broad range of stakeholders including patient partners the trial will address a broadly applicable patient-prioritized question Tranexamic acid is readily available inexpensive and has an established side effect profile Results of this trial are highly generalizable and will broadly impact the care of patients with MDS and AML
STUDY OBJECTIVES To evaluate the feasibility of tranexamic acid TXA that will evaluate the efficacy and safety of treatments to minimize bleeding in patients with MDS and AML treated in the outpatient setting
METHODOLOGY The investigators will conduct a multicenter pilot randomized control trial RCT for outpatients 18 years of age with MDS and AML Patients with MDS and AML with low platelet counts will receive TXA a medication that prevents clots from dissolving TXA is commonly used in other clinical settings but have not been studied in patients with MDS or AML receiving outpatient chemotherapy ie chemotherapy that can be given from clinic rather than a hospital In this study 50 of patients will be randomized like the flip of a coin to receive the medication the investigators are studying The other 50 of patients will receive a matching placebo
OUTCOMES The primary feasibility outcome is the ability to enroll a mean of 1 patient per site per month
SITES AND DURATION The investigators will initially enroll patients from 10-15 sites across Canada The expected duration of enrollment is 2 years
SIGNIFICANCE With a broad range of stakeholders including patient partners the trial will address a broadly applicable patient-prioritized question Tranexamic acid is readily available inexpensive and has an established side effect profile Results of this trial are highly generalizable and will broadly impact the care of patients with MDS and AML
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