Trial Outcomes & Findings for A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia (NCT NCT03806556)
NCT ID: NCT03806556
Last Updated: 2021-09-20
Results Overview
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 patients with hematologic malignancies or solid tumors by reported adverse events, serious adverse events and death.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug
Results posted on
2021-09-20
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=6 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.5 years
n=5 Participants
|
11 years
n=7 Participants
|
11 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Diagnosis
Lymphoid Leukemia
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Diagnosis
Myeloid Leukemia
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diagnosis
Lymphoma
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diagnosis
Solid Tumor
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Type of Therapy
Chemotherapy
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Type of Therapy
Autologous Hematopoietic Stem Cell Transplant
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Type of Therapy
Allogeneic Hematopoietic Stem Cell Transplant
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drugAdverse 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 patients with hematologic malignancies or solid tumors by reported adverse events, serious adverse events and death.
Outcome measures
| Measure |
Tranexamic Acid
n=6 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
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 v4.03
Grade 4 Adverse Events : Platelet Count Decreased
|
6 Participants
|
5 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Anemia
|
4 Participants
|
4 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Anorexia
|
0 Participants
|
2 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Bone Pain
|
1 Participants
|
0 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Catheter Related Infection
|
3 Participants
|
1 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Vomiting
|
0 Participants
|
2 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Febrile Neutropenia
|
2 Participants
|
3 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Fever
|
0 Participants
|
1 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Hypoalbuminemia
|
1 Participants
|
0 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Hypotension
|
0 Participants
|
1 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Hypoxia
|
0 Participants
|
1 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Hypophosphatemia
|
0 Participants
|
1 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Rash Maculo-Papular
|
0 Participants
|
2 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Nausea
|
0 Participants
|
1 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Mucositis Oral
|
0 Participants
|
1 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Sinusitis
|
0 Participants
|
1 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Skin Infection
|
1 Participants
|
0 Participants
|
|
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 v4.03
Grade 3 Adverse Events : White Blood Cell Decreases
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Platelet Count Decreased
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 3 Adverse Events : Blood Bilirubin Increased
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Anemia
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Anorexia
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Bone Pain
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Catheter Related Infection
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Vomiting
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Febrile Neutropenia
|
0 Participants
|
1 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Fever
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Hypoalbuminemia
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Hypotension
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Hypoxia
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Hypophosphatemia
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Rash Maculo-Papular
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Nausea
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Mucositis Oral
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Sinusitis
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Skin Infection
|
0 Participants
|
0 Participants
|
|
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 v4.03
Grade 4 Adverse Events : White Blood Cell Decreases
|
6 Participants
|
5 Participants
|
|
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 v4.03
Grade 4 Adverse Events : Blood Bilirubin Increased
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From time of recruitment of the first patient until the last patient is enrolled, up to 16 months in durationNumber 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 number of eligible patients who consent to study inclusion and the number of consented patients activated to the study drug, organized in visual form by CONSORT diagram.
Outcome measures
| Measure |
Tranexamic Acid
n=693 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
Feasibility of Tranexamic Acid as an Adjunct to Standard Therapy: Number of Participants Eligible and Recruited
Eligible for Enrollment
|
31 Participants
|
—
|
|
Feasibility of Tranexamic Acid as an Adjunct to Standard Therapy: Number of Participants Eligible and Recruited
Screened for Complete Inclusion/Exclusion Criteria
|
148 Participants
|
—
|
|
Feasibility of Tranexamic Acid as an Adjunct to Standard Therapy: Number of Participants Eligible and Recruited
Consented to Participate
|
11 Participants
|
—
|
|
Feasibility of Tranexamic Acid as an Adjunct to Standard Therapy: Number of Participants Eligible and Recruited
Assessed for Eligibility
|
693 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days after activation of study drugProportion 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).
Outcome measures
| Measure |
Tranexamic Acid
n=6 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
World Health Organization (WHO) Bleeding Scale Grade 2 or Higher Bleeding
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 days after activation of study drugNumber of platelet and red blood cell transfusions per patient during the first 30 days post prescription activation of study drug
Outcome measures
| Measure |
Tranexamic Acid
n=6 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
Number of Platelet and Red Blood Cell Transfusions
Number of platelet transfusions per patient
|
1.5 transfusions
Interval 0.0 to 2.0
|
4 transfusions
Interval 1.0 to 9.0
|
|
Number of Platelet and Red Blood Cell Transfusions
Number of pRBC transfusions per patient
|
0.5 transfusions
Interval 0.0 to 3.0
|
1 transfusions
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 30 days after activation of study drugNumber 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).
Outcome measures
| Measure |
Tranexamic Acid
n=6 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
Number of Days Alive and Without WHO Grade 2 Bleeding or Greater
|
5.5 days
Interval 2.0 to 8.0
|
10.4 days
Interval 1.0 to 18.0
|
SECONDARY outcome
Timeframe: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drugAny venous or arterial thrombosis on standard diagnostic imaging post-randomization
Outcome measures
| Measure |
Tranexamic Acid
n=6 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
The Occurrence of Thromboembolic Adverse Events and Serious Adverse Events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drugProportion of patients with bleeding of any grade as assessed by WHO bleeding score, after activation of study drug
Outcome measures
| Measure |
Tranexamic Acid
n=6 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
Bleeding of Any Grade
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drugHighest 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).
Outcome measures
| Measure |
Tranexamic Acid
n=6 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 Participants
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study Period
Grade 1 Bleeding
|
4 Participants
|
2 Participants
|
|
Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study Period
Grade 2 Bleeding
|
0 Participants
|
3 Participants
|
|
Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study Period
Grade 3 Bleeding
|
0 Participants
|
0 Participants
|
|
Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study Period
Grade 4 Bleeding
|
0 Participants
|
0 Participants
|
|
Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study Period
Grade 5 Bleeding
|
0 Participants
|
0 Participants
|
Adverse Events
Tranexamic Acid
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tranexamic Acid
n=6 participants at risk
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 participants at risk
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
Blood and lymphatic system disorders
White Blood Cell Decreased
|
100.0%
6/6 • 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
|
100.0%
5/5 • 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
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
100.0%
6/6 • 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
|
100.0%
5/5 • 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
|
|
Hepatobiliary disorders
Blood Bilirubin Increased
|
16.7%
1/6 • 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
|
0.00%
0/5 • 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
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • 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
|
20.0%
1/5 • 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
|
Other adverse events
| Measure |
Tranexamic Acid
n=6 participants at risk
Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria
|
Placebo
n=5 participants at risk
Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • 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
|
80.0%
4/5 • 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
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • 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
|
40.0%
2/5 • 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
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
16.7%
1/6 • 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
|
0.00%
0/5 • 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
|
|
Infections and infestations
Catheter Related Infection
|
50.0%
3/6 • 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
|
20.0%
1/5 • 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
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 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
|
40.0%
2/5 • 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
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
33.3%
2/6 • 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
|
60.0%
3/5 • 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
|
|
General disorders
Fever
|
0.00%
0/6 • 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
|
20.0%
1/5 • 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
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • 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
|
0.00%
0/5 • 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
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 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
|
20.0%
1/5 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • 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
|
20.0%
1/5 • 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
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • 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
|
20.0%
1/5 • 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
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.00%
0/6 • 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
|
40.0%
2/5 • 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
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 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
|
20.0%
1/5 • 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
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/6 • 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
|
20.0%
1/5 • 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
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • 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
|
20.0%
1/5 • 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
|
|
Infections and infestations
Skin Infection
|
16.7%
1/6 • 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
|
0.00%
0/5 • 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
|
Additional Information
Meghan McCormick, MD MS
University of Pittsburgh Medical Center
Phone: 412-692-6938
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place