Adults 2 to 21, any sex, with Pediatric Cancer or Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety and Tolerability of Tranexamic Acid in Participants as the Number of Patients With Any Adverse Events and Serious Adverse Events (SAE) as Assessed by CTCAE v4.03Primary· From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug
Adverse Events and Serious Adverse Events (SAE) will be collected on subjects throughout their participation in the study and up to 30 days following discontinuation of the study drug, regardless of attribution. Adverse events and serious adverse events will be tabulated by type and grade according to the NCI CTCAE v 4.03.
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. Analysis limited to a descriptive assessment of the safety of tranexamic acid in patient
Grade 3 Adverse Events : Anemia
Group
Value
95% CI
Tranexamic Acid
4
Placebo
4
Grade 3 Adverse Events : Anorexia
Group
Value
95% CI
Tranexamic Acid
0
Placebo
2
Grade 3 Adverse Events : Bone Pain
Group
Value
95% CI
Tranexamic Acid
1
Placebo
0
Grade 3 Adverse Events : Catheter Related Infection
Group
Value
95% CI
Tranexamic Acid
3
Placebo
1
Grade 3 Adverse Events : Vomiting
Group
Value
95% CI
Tranexamic Acid
0
Placebo
2
Grade 3 Adverse Events : Febrile Neutropenia
Group
Value
95% CI
Tranexamic Acid
2
Placebo
3
Grade 3 Adverse Events : Fever
Group
Value
95% CI
Tranexamic Acid
0
Placebo
1
Grade 3 Adverse Events : Hypoalbuminemia
Group
Value
95% CI
Tranexamic Acid
1
Placebo
0
Feasibility of Tranexamic Acid as an Adjunct to Standard Therapy: Number of Participants Eligible and RecruitedPrimary· From time of recruitment of the first patient until the last patient is enrolled, up to 16 months in duration
Number of participants eligible for study enrollment and recruited.
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. A descriptive assessment of feasibility of recruitment by monitoring number of patients screened, number of patients eligible for enrollment and rate of recruitment (both start-up and ongoing) during study period to be completed by collecting data on the number of patients screened, the number of patients eligible for study inclusion, the numb
Assessed for Eligibility
Group
Value
95% CI
Overall Study
693
Screened for Complete Inclusion/Exclusion Criteria
Group
Value
95% CI
Overall Study
148
Eligible for Enrollment
Group
Value
95% CI
Overall Study
31
Consented to Participate
Group
Value
95% CI
Overall Study
11
World Health Organization (WHO) Bleeding Scale Grade 2 or Higher BleedingSecondary· 30 days after activation of study drug
Proportion of patients with bleeding of WHO grade 2 or above, after activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).
Group
Value
95% CI
Tranexamic Acid
0
Placebo
3
Number of Platelet and Red Blood Cell TransfusionsSecondary· 30 days after activation of study drug
Number of platelet and red blood cell transfusions per patient during the first 30 days post prescription activation of study drug
Number of platelet transfusions per patient
Group
Value
95% CI
Tranexamic Acid
1.5
0 – 2
Placebo
4
1 – 9
Number of pRBC transfusions per patient
Group
Value
95% CI
Tranexamic Acid
0.5
0 – 3
Placebo
1
0 – 2
Number of Days Alive and Without WHO Grade 2 Bleeding or GreaterSecondary· 30 days after activation of study drug
Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).
Group
Value
95% CI
Tranexamic Acid
5.5
2 – 8
Placebo
10.4
1 – 18
The Occurrence of Thromboembolic Adverse Events and Serious Adverse EventsSecondary· From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug
Any venous or arterial thrombosis on standard diagnostic imaging post-randomization
Group
Value
95% CI
Tranexamic Acid
0
Placebo
0
Bleeding of Any GradeSecondary· From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug
Proportion of patients with bleeding of any grade as assessed by WHO bleeding score, after activation of study drug
Group
Value
95% CI
Tranexamic Acid
4
Placebo
5
Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study PeriodSecondary· From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug
Highest grade of bleeding (as measured on WHO bleeding scale) during study period in each enrolled patient. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).
Grade 1 Bleeding
Group
Value
95% CI
Tranexamic Acid
4
Placebo
2
Grade 2 Bleeding
Group
Value
95% CI
Tranexamic Acid
0
Placebo
3
Grade 3 Bleeding
Group
Value
95% CI
Tranexamic Acid
0
Placebo
0
Grade 4 Bleeding
Group
Value
95% CI
Tranexamic Acid
0
Placebo
0
Grade 5 Bleeding
Group
Value
95% CI
Tranexamic Acid
0
Placebo
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of activation of the study drug up to and including 30 days after the last dose of the study drug, an average of 41 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluates the use of tranexamic acid (TXA) in addition to standard therapy in children receiving chemotherapy or blood and/or marrow transplantation to decrease the risk of bleeding. Half of participants will receive tranexamic acid and half of participants will receive placebo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Meghan McCormick
Last refreshed: 20 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03806556.