Trial Outcomes & Findings for TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia (NCT NCT03136445)

Last Updated: 2025-10-28

Results Overview

The proportion of patients who die or have bleeding of WHO grade 2 or above by WHO criteria during the first 30 days from the first dose of trial treatment, or planned first dose for those participants who do not receive treatment. A time-to-event analysis will be used to determine this proportion to ensure that all patients are included in the primary outcome analysis, not just those who are followed up for the full 30 days. Any patients lost to follow-up will be included in the analysis and censored at the time that they were lost.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

616 participants

Primary outcome timeframe

The first 30 days from first dose of trial treatment

Results posted on

2025-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Arm Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Overall Study STARTED	310	306
Overall Study COMPLETED	300	297
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 participant missing this information

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: The first 30 days from first dose of trial treatment

Population: Participants with primary outcome data reported

Outcome measures

Outcome measures
Measure	Intervention Arm n=298 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=295 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
The Proportion of Patients Who Die or Have Bleeding of WHO Grade 2 or Above by WHO Criteria During the First 30 Days From the First Dose of Trial Treatment, or Planned First Dose for Those Participants Who do Not Receive Treatment.	31.7 percentage of participants Interval 26.6 to 37.4	34.2 percentage of participants Interval 29.0 to 40.0

SECONDARY outcome

Timeframe: The first 30 days from first dose of trial treatment .

Population: Participants with primary outcome data reported

Number of days where WHO grade 2 or above bleeding has been recorded bleeding using WHO bleeding criteria.

Outcome measures

Outcome measures
Measure	Intervention Arm n=298 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=295 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant.	3.1 percentage of days Standard Deviation 9.5	3.2 percentage of days Standard Deviation 7.8

SECONDARY outcome

Timeframe: The first 30 days from first dose of trial treatment.

Population: Participants with primary outcome data reported

Bleeding assessed using WHO bleeding criteria. Time to first episode of bleeding of WHO grade 2 or above was estimated using a cumulative incidence function, with death as a competing risk. The lower quartile for the time is reported as the median was not estimable.

Outcome measures

Outcome measures
Measure	Intervention Arm n=30 Days Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=30 Days Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Time to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30.	NA Lower quartile for number of days Interval 10.5 to Median is not estimable due to insufficient number of events	NA Lower quartile for number of days Interval 8.5 to Median is not estimable due to insufficient number of events

SECONDARY outcome

Timeframe: The first 30 days from first dose of trial treatment.

Population: Data is only presented for participants who experienced at least one bleed

Measured using WHO bleeding criteria (The higher the grade, the most severe the bleed). Grade 0: no bleeding Grade 1: petechial bleeding Grade 2: mild blood loss (clinically significant) Grade 3: gross blood loss, requires transfusion(severe) Grade 4: debilitating blood loss, retinal or cerebral associated with fatality

Outcome measures

Outcome measures
Measure	Intervention Arm n=205 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=225 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Highest Grade of Bleeding a Patient Experiences up to Study Day 30. Grade 0	7 Participants	6 Participants
Highest Grade of Bleeding a Patient Experiences up to Study Day 30. Grade unassigned	0 Participants	1 Participants
Highest Grade of Bleeding a Patient Experiences up to Study Day 30. Grade 2	85 Participants	93 Participants
Highest Grade of Bleeding a Patient Experiences up to Study Day 30. Grade 3	0 Participants	3 Participants
Highest Grade of Bleeding a Patient Experiences up to Study Day 30. Grade 4	2 Participants	1 Participants
Highest Grade of Bleeding a Patient Experiences up to Study Day 30. Grade 1	111 Participants	121 Participants

SECONDARY outcome

Timeframe: The first 30 days from first dose of trial treatment.

Population: Participants with primary outcome data reported

Measured by number of recorded platelet transfusions per patient.

Outcome measures

Outcome measures
Measure	Intervention Arm n=298 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=295 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Number of Platelet Transfusions Per Patient up to Study Day 30.	3 platelet units Interval 1.0 to 6.0	3 platelet units Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: The first 30 days from first dose of trial treatment.

Population: Participants with primary outcome data reported

Measured by number of recorded red cell transfusions per patient.

Outcome measures

Outcome measures
Measure	Intervention Arm n=298 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=295 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Number of Red Cell Transfusions Per Patient up to Study Day 30.	2 Red cell units Interval 0.0 to 4.0	2 Red cell units Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: The first 30 days from first dose of trial treatment.

Population: Participants with primary outcome data reported

Measured by calculating number of patients surviving at least 30 days without a platelet transfusion.

Outcome measures

Outcome measures
Measure	Intervention Arm n=298 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=295 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Proportion of Patients Surviving at Least 30 Days Without a Platelet Transfusion.	8.3 proportion Interval 5.4 to 11.9	6.4 proportion Interval 3.9 to 9.7

SECONDARY outcome

Timeframe: The first 30 days from first dose of trial treatment.

Population: Participants with primary outcome data reported

Measured by calculating the number of patients surviving at least 30 days without a red cell transfusion.

Outcome measures

Outcome measures
Measure	Intervention Arm n=298 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=295 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Proportion of Patients Surviving at Least 30 Days Without a Red Cell Transfusion.	29.4 proportion Interval 24.1 to 34.8	20.5 proportion Interval 16.0 to 25.4

SECONDARY outcome

Timeframe: Up to and including 120 days from the first administration of investigational medicinal product (IMP).

Measured by calculating number of patients developing clinically diagnosed thrombotic events within 120 days of Treatment Day 1 i.e the first day that the IMP is administered.

Outcome measures

Outcome measures
Measure	Intervention Arm n=300 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=297 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Number of Participants With a Thrombotic Event From First Administration of Trial Treatment up to and Including 120 Days After the First Dose of Trial Treatment is Received (N)	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to and including 60 days from the first administration of IMP.

Measured by calculating number of patients developing Veno-occlusive Disease (VOD; Sinusoidal obstructive syndrome, SOS) within 60 days of Treatment Day 1 i.e the first day that the IMP is administered.

Outcome measures

Outcome measures
Measure	Intervention Arm n=300 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=297 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment.	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to and including 120 days from the first administration of IMP.

Population: 4 Participants were missing mortality data and so weren't analysd

Measured by calculating number of deaths in first 30 days and 120 days after Treatment Day 1 i.e the first day that the IMP is administered.

Outcome measures

Outcome measures
Measure	Intervention Arm n=298 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=295 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
All-cause Mortality During the First 30 Days and 120 Days After the First Dose of Trial Treatment is Administered. 30 days	2.9 proportion Interval 1.5 to 5.8	1.1 proportion Interval 0.4 to 3.3
All-cause Mortality During the First 30 Days and 120 Days After the First Dose of Trial Treatment is Administered. 120 days	8.7 proportion Interval 5.9 to 12.8	5.3 proportion Interval 3.2 to 8.8

SECONDARY outcome

Timeframe: Up to and including 120 days from the first administration of IMP.

Measured by calculating number of deaths due to thrombosis during the first 120 days after Treatment Day 1 i.e the first day that the IMP is administered.

Outcome measures

Outcome measures
Measure	Intervention Arm n=300 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=297 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Death Due to Thrombosis During the First 120 Days After the First Dose of Trial Treatment is Administered.	0 percent	0 percent

SECONDARY outcome

Timeframe: Up to and including 30 days from the first administration of IMP.

Measured by calculating number of deaths due to bleeding during the first 30 days

Outcome measures

Outcome measures
Measure	Intervention Arm n=300 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=297 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Death Due to Bleeding During the First 30 Days After the First Dose of Trial Treatment is Administered.	0 percent	0 percent

SECONDARY outcome

Timeframe: Up to and including 60 days from the first administration of IMP.

Measured by calculating the total number of SAE's reported from first administration of IMP.

Outcome measures

Outcome measures
Measure	Intervention Arm n=300 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=297 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered. Total number of serious adverse events (SAE) up to day 60	94 Serious adverse events	103 Serious adverse events
Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered. Sepsis	25 Serious adverse events	27 Serious adverse events
Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered. Organ failure	4 Serious adverse events	7 Serious adverse events
Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered. GvHD	5 Serious adverse events	7 Serious adverse events
Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered. Transfusion reaction	2 Serious adverse events	4 Serious adverse events
Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered. Fever	24 Serious adverse events	20 Serious adverse events
Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered. Other SAEs	34 Serious adverse events	38 Serious adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured during first 30 days from first dose of IMP.

Population: Days platelet count count was recorded (so risk of thrombocytopenia could be detected)

Measured by number of days that the patient's laboratory results indicate that the patient is thrombocytopenic.

Outcome measures

Outcome measures
Measure	Intervention Arm n=5271 Days a platelet count should be reported Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=5326 Days a platelet count should be reported Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Proportion of Days With Thrombocytopenia (≤10x10⁹/L, ≤30x10⁹L, ≤50x10⁹/L). Thrombocytopenia (≤10x109/L)	13.7 Days with thrombocytopenia Standard Deviation 13.9	15.3 Days with thrombocytopenia Standard Deviation 15.4
Proportion of Days With Thrombocytopenia (≤10x10⁹/L, ≤30x10⁹L, ≤50x10⁹/L). Thrombocytopenia (≤30x109/L)	64.8 Days with thrombocytopenia Standard Deviation 25.9	60.2 Days with thrombocytopenia Standard Deviation 24.8
Proportion of Days With Thrombocytopenia (≤10x10⁹/L, ≤30x10⁹L, ≤50x10⁹/L). Thrombocytopenia (≤50x109/L)	78.2 Days with thrombocytopenia Standard Deviation 22.3	74 Days with thrombocytopenia Standard Deviation 23.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured during first 30 days from first dose of IMP.

Population: Participants with at least one platelet transfusion

Reasons for platelet transfusions as documented by clinician.

Outcome measures

Outcome measures
Measure	Intervention Arm n=1205 Number of platelet transfusions Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=1264 Number of platelet transfusions Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Reasons for Platelet Transfusions. Active bleeding	59 Platelet transfusions	66 Platelet transfusions
Reasons for Platelet Transfusions. Missing data for reasons for platelet transfusions	10 Platelet transfusions	6 Platelet transfusions
Reasons for Platelet Transfusions. Prophylaxis for platelet count ≤10x109/L	438 Platelet transfusions	456 Platelet transfusions
Reasons for Platelet Transfusions. Prophylaxis and platelet count >10x109/L	671 Platelet transfusions	705 Platelet transfusions
Reasons for Platelet Transfusions. Invasive procedure	27 Platelet transfusions	31 Platelet transfusions

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured during first 30 days from first dose of IMP.

Population: Participants with at least one red cell transfusion

Reasons for red cell transfusions as documented by clinician.

Outcome measures

Outcome measures
Measure	Intervention Arm n=766 Number of red cell transfusions given Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=845 Number of red cell transfusions given Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Reasons for Red Cell Transfusions. Other	17 Red cell transfusions	14 Red cell transfusions
Reasons for Red Cell Transfusions. Low haemoglobin	736 Red cell transfusions	818 Red cell transfusions
Reasons for Red Cell Transfusions. Active bleeding	7 Red cell transfusions	7 Red cell transfusions
Reasons for Red Cell Transfusions. Missing data for reasons for red cell transfusions	6 Red cell transfusions	6 Red cell transfusions

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured during first 30 days from first dose of IMP.

Population: Participants with fever data reported

Highest daily temperature ≥ 38.1°C

Outcome measures

Outcome measures
Measure	Intervention Arm n=4534 Days a temperature should be reported Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=4558 Days a temperature should be reported Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Proportion of Days With Fever	20 Days Standard Deviation 21.5	17.7 Days Standard Deviation 20.2

Adverse Events

Intervention Arm

Serious events: 77 serious events

Other events: 8 other events

Deaths: 23 deaths

Control Arm

Serious events: 82 serious events

Other events: 5 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Arm n=300 participants at risk Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=297 participants at risk Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Infections and infestations Sepsis (at least one event)	8.3% 25/300 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60	9.1% 27/297 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60
General disorders Organ Failure (at least one event)	1.3% 4/300 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60	2.0% 6/297 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60
Immune system disorders GvHD (at least one event)	1.7% 5/300 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60	2.4% 7/297 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60
Blood and lymphatic system disorders Transfusion reaction (at least one event)	0.33% 1/300 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60	1.3% 4/297 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60
Infections and infestations Fever (at least one event)	6.7% 20/300 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60	6.7% 20/297 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60
General disorders Other SAEs (at least one event)	9.7% 29/300 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60	11.8% 35/297 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60

Other adverse events

Other adverse events
Measure	Intervention Arm n=300 participants at risk Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=297 participants at risk Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
Vascular disorders Venous thromboembolisms	2.3% 7/300 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60	1.3% 4/297 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60
Vascular disorders Arterial ischaemic events	0.33% 1/300 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60	0.34% 1/297 • Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60

Additional Information

A/Prof Lise Estcourt

NHS Blood and Transplant

Phone: 44 1865 387789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention Arm n=310 Participants Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Control Arm n=306 Participants Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets	Total n=616 Participants Total of all reporting groups
Age, Continuous	55.8 years STANDARD_DEVIATION 12.3 • n=309 Participants • 1 participant missing this information	55.3 years STANDARD_DEVIATION 12.1 • n=306 Participants • 1 participant missing this information	55.6 years STANDARD_DEVIATION 12.2 • n=615 Participants • 1 participant missing this information
Sex/Gender, Customized Male	194 Participants n=309 Participants • 1 participant missing this information	186 Participants n=306 Participants • 1 participant missing this information	380 Participants n=615 Participants • 1 participant missing this information
Sex/Gender, Customized Female	115 Participants n=309 Participants • 1 participant missing this information	120 Participants n=306 Participants • 1 participant missing this information	235 Participants n=615 Participants • 1 participant missing this information
Race/Ethnicity, Customized White	272 Participants n=310 Participants	266 Participants n=306 Participants	538 Participants n=616 Participants
Race/Ethnicity, Customized Asian	7 Participants n=310 Participants	14 Participants n=306 Participants	21 Participants n=616 Participants
Race/Ethnicity, Customized Black African	1 Participants n=310 Participants	1 Participants n=306 Participants	2 Participants n=616 Participants
Race/Ethnicity, Customized Black Caribbean	2 Participants n=310 Participants	1 Participants n=306 Participants	3 Participants n=616 Participants
Race/Ethnicity, Customized Arab / Other Middle East ancestry	1 Participants n=310 Participants	3 Participants n=306 Participants	4 Participants n=616 Participants
Race/Ethnicity, Customized Aboriginal	2 Participants n=310 Participants	1 Participants n=306 Participants	3 Participants n=616 Participants
Race/Ethnicity, Customized Other	4 Participants n=310 Participants	5 Participants n=306 Participants	9 Participants n=616 Participants
Race/Ethnicity, Customized Unknown / Not Stated	17 Participants n=310 Participants	13 Participants n=306 Participants	30 Participants n=616 Participants
Race/Ethnicity, Customized (Mixed ethnic group:) White / Black Caribbean	2 Participants n=310 Participants	0 Participants n=306 Participants	2 Participants n=616 Participants
Race/Ethnicity, Customized (Mixed ethnic group:) White / Other	1 Participants n=310 Participants	1 Participants n=306 Participants	2 Participants n=616 Participants
Race/Ethnicity, Customized (Mixed ethnic group:) Other mixed ethnic group	1 Participants n=310 Participants	1 Participants n=306 Participants	2 Participants n=616 Participants
Height	172.4 cm STANDARD_DEVIATION 10.1 • n=305 Participants • 6 participants missing this information	171.7 cm STANDARD_DEVIATION 9.7 • n=305 Participants • 6 participants missing this information	172.1 cm STANDARD_DEVIATION 9.9 • n=610 Participants • 6 participants missing this information
Weight	81.1 kg STANDARD_DEVIATION 16.6 • n=307 Participants • 4 participants missing this information	80.5 kg STANDARD_DEVIATION 17.6 • n=305 Participants • 4 participants missing this information	80.8 kg STANDARD_DEVIATION 17.1 • n=612 Participants • 4 participants missing this information
Diagnosis AML	135 Participants n=309 Participants • 1 participant missing this information	129 Participants n=306 Participants • 1 participant missing this information	264 Participants n=615 Participants • 1 participant missing this information
Diagnosis ALL	9 Participants n=309 Participants • 1 participant missing this information	11 Participants n=306 Participants • 1 participant missing this information	20 Participants n=615 Participants • 1 participant missing this information
Diagnosis APL	0 Participants n=309 Participants • 1 participant missing this information	2 Participants n=306 Participants • 1 participant missing this information	2 Participants n=615 Participants • 1 participant missing this information
Diagnosis CML	5 Participants n=309 Participants • 1 participant missing this information	7 Participants n=306 Participants • 1 participant missing this information	12 Participants n=615 Participants • 1 participant missing this information
Diagnosis CLL	3 Participants n=309 Participants • 1 participant missing this information	4 Participants n=306 Participants • 1 participant missing this information	7 Participants n=615 Participants • 1 participant missing this information
Diagnosis Hodgkin's Lymphoma	17 Participants n=309 Participants • 1 participant missing this information	12 Participants n=306 Participants • 1 participant missing this information	29 Participants n=615 Participants • 1 participant missing this information
Diagnosis Non-Hodgkin Lymphoma	70 Participants n=309 Participants • 1 participant missing this information	62 Participants n=306 Participants • 1 participant missing this information	132 Participants n=615 Participants • 1 participant missing this information
Diagnosis Myeloma	35 Participants n=309 Participants • 1 participant missing this information	36 Participants n=306 Participants • 1 participant missing this information	71 Participants n=615 Participants • 1 participant missing this information
Diagnosis MDS	18 Participants n=309 Participants • 1 participant missing this information	22 Participants n=306 Participants • 1 participant missing this information	40 Participants n=615 Participants • 1 participant missing this information
Diagnosis Other	17 Participants n=309 Participants • 1 participant missing this information	21 Participants n=306 Participants • 1 participant missing this information	38 Participants n=615 Participants • 1 participant missing this information
Treatment plan Induction chemotherapy	70 Participants n=309 Participants • 1 participant missing this information	72 Participants n=306 Participants • 1 participant missing this information	142 Participants n=615 Participants • 1 participant missing this information
Treatment plan Consolidation chemotherapy	49 Participants n=309 Participants • 1 participant missing this information	46 Participants n=306 Participants • 1 participant missing this information	95 Participants n=615 Participants • 1 participant missing this information
Treatment plan Autograft	111 Participants n=309 Participants • 1 participant missing this information	105 Participants n=306 Participants • 1 participant missing this information	216 Participants n=615 Participants • 1 participant missing this information
Treatment plan Allograft	77 Participants n=309 Participants • 1 participant missing this information	79 Participants n=306 Participants • 1 participant missing this information	156 Participants n=615 Participants • 1 participant missing this information
Treatment plan Other	2 Participants n=309 Participants • 1 participant missing this information	4 Participants n=306 Participants • 1 participant missing this information	6 Participants n=615 Participants • 1 participant missing this information
Platelet count at consent	116.2 10^9 cells/L STANDARD_DEVIATION 103.3 • n=309 Participants • 4 participants missing this information	113.1 10^9 cells/L STANDARD_DEVIATION 94.9 • n=303 Participants • 4 participants missing this information	114.7 10^9 cells/L STANDARD_DEVIATION 99.1 • n=612 Participants • 4 participants missing this information
Platelet count at randomisation	31.7 10^9 cells/L STANDARD_DEVIATION 18.1 • n=309 Participants • 3 participants missing this information	29.2 10^9 cells/L STANDARD_DEVIATION 13.3 • n=304 Participants • 3 participants missing this information	30.4 10^9 cells/L STANDARD_DEVIATION 15.9 • n=613 Participants • 3 participants missing this information
Haemoglobin at consent	100.2 G/L STANDARD_DEVIATION 18.1 • n=308 Participants • 5 participants missing this information	98.5 G/L STANDARD_DEVIATION 18 • n=303 Participants • 5 participants missing this information	99.4 G/L STANDARD_DEVIATION 18 • n=611 Participants • 5 participants missing this information
Haemoglobin at randomisation	94.3 G/L STANDARD_DEVIATION 16 • n=309 Participants • 3 participants missing this information	91.2 G/L STANDARD_DEVIATION 15.8 • n=304 Participants • 3 participants missing this information	92.8 G/L STANDARD_DEVIATION 15.9 • n=613 Participants • 3 participants missing this information
FACT-G subscale score at randomisation Physical well-being	16.4 scores on a scale STANDARD_DEVIATION 7.1 • n=272 Participants • Some participants are missing data for these QOL questionnaires	17.1 scores on a scale STANDARD_DEVIATION 6.7 • n=278 Participants • Some participants are missing data for these QOL questionnaires	16.7 scores on a scale STANDARD_DEVIATION 6.9 • n=550 Participants • Some participants are missing data for these QOL questionnaires
FACT-G subscale score at randomisation Social/family well-being	23.8 scores on a scale STANDARD_DEVIATION 4.7 • n=272 Participants • Some participants are missing data for these QOL questionnaires	23.7 scores on a scale STANDARD_DEVIATION 4.5 • n=278 Participants • Some participants are missing data for these QOL questionnaires	23.7 scores on a scale STANDARD_DEVIATION 4.6 • n=550 Participants • Some participants are missing data for these QOL questionnaires
FACT-G subscale score at randomisation Emotional well-being	18.3 scores on a scale STANDARD_DEVIATION 4.1 • n=271 Participants • Some participants are missing data for these QOL questionnaires	18.5 scores on a scale STANDARD_DEVIATION 4.3 • n=275 Participants • Some participants are missing data for these QOL questionnaires	18.4 scores on a scale STANDARD_DEVIATION 4.2 • n=546 Participants • Some participants are missing data for these QOL questionnaires
FACT-G subscale score at randomisation Functional well-being	14.3 scores on a scale STANDARD_DEVIATION 6.2 • n=270 Participants • Some participants are missing data for these QOL questionnaires	14.3 scores on a scale STANDARD_DEVIATION 6.8 • n=272 Participants • Some participants are missing data for these QOL questionnaires	14.3 scores on a scale STANDARD_DEVIATION 6.5 • n=542 Participants • Some participants are missing data for these QOL questionnaires
FACT-G total score at randomisation	72.6 scores on a scale STANDARD_DEVIATION 14.5 • n=268 Participants • 76 participants missing this information	73.6 scores on a scale STANDARD_DEVIATION 16.6 • n=272 Participants • 76 participants missing this information	73.1 scores on a scale STANDARD_DEVIATION 15.6 • n=540 Participants • 76 participants missing this information
FACT-Th total score at randomisation	125.7 scores on a scale STANDARD_DEVIATION 22 • n=266 Participants • 79 participants missing this information	127.6 scores on a scale STANDARD_DEVIATION 24.5 • n=271 Participants • 79 participants missing this information	126.7 scores on a scale STANDARD_DEVIATION 23.3 • n=537 Participants • 79 participants missing this information
Medical history Diabetes requiring treatment	21 Participants n=309 Participants • Some participants are missing data for medical history	20 Participants n=306 Participants • Some participants are missing data for medical history	41 Participants n=615 Participants • Some participants are missing data for medical history
Medical history Hypertension requiring treatment	42 Participants n=309 Participants • Some participants are missing data for medical history	40 Participants n=306 Participants • Some participants are missing data for medical history	82 Participants n=615 Participants • Some participants are missing data for medical history
Medical history Renal impairment requiring treatment	6 Participants n=309 Participants • Some participants are missing data for medical history	5 Participants n=306 Participants • Some participants are missing data for medical history	11 Participants n=615 Participants • Some participants are missing data for medical history
Medical history Confirmed invasive fungal infection	10 Participants n=309 Participants • Some participants are missing data for medical history	3 Participants n=306 Participants • Some participants are missing data for medical history	13 Participants n=615 Participants • Some participants are missing data for medical history
Medical history Other malignancy	10 Participants n=309 Participants • Some participants are missing data for medical history	8 Participants n=306 Participants • Some participants are missing data for medical history	18 Participants n=615 Participants • Some participants are missing data for medical history
Medical history HLA antibodies	1 Participants n=307 Participants • Some participants are missing data for medical history	6 Participants n=306 Participants • Some participants are missing data for medical history	7 Participants n=613 Participants • Some participants are missing data for medical history