TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytop... | NCT03136445

ID	Type	Description	Link
2014-001513-35	EudraCT Number
ISRCTN73545489	Registry Identifier	ISRCTN Registry

Name	Class
National Health and Medical Research Council, Australia	OTHER
Monash University	OTHER

Label	Type	Description	Intervention Names
Intervention Arm	Experimental	Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.	Drug: Tranexamic acid (TXA).
Control Arm	Placebo Comparator	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic acid (TXA).	Drug	IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.	Intervention Arm

Measure	Description	Time Frame
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.	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.	The first 30 days from first dose of trial treatment

Measure	Description	Time Frame
Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant.	Number of days where WHO grade 2 or above bleeding has been recorded bleeding using WHO bleeding criteria.	The first 30 days from first dose of trial treatment .
Time to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30.

Measure	Description	Time Frame
Proportion of Days With Thrombocytopenia (≤10x10⁹/L, ≤30x10⁹L, ≤50x10⁹/L).	Measured by number of days that the patient's laboratory results indicate that the patient is thrombocytopenic.	Measured during first 30 days from first dose of IMP.
Reasons for Platelet Transfusions.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients are eligible for this trial if:

Aged ≥18 years of age
Confirmed diagnosis of a haematological malignancy
Undergoing chemotherapy, or chemotherapy is planned, or haematopoietic stem cell transplantation
Anticipated to have a hypoproliferative thrombocytopenia resulting in a platelet count of ≤10x10⁹/L for ≥ 5 days
Able to comply with treatment and monitoring

Exclusion Criteria:

A patient will not be eligible for this trial if he/she fulfils one or more of the following criteria:

Patients with a past history or current diagnosis of arterial or venous thromboembolic disease including myocardial infarction, peripheral vascular disease and retinal arterial or venous thrombosis.
Diagnosis of acute promyelocytic leukaemia (APML) and undergoing induction chemotherapy
Patients with a diagnosis/previous history of veno-occlusive disease (also called sinusoidal obstruction syndrome)
Patients with known inherited or acquired prothrombotic disorders e.g.
1. Lupus anticoagulant
2. Positive antiphospholipids
Patients receiving any pro-coagulant agents (e.g. DDAVP, recombinant Factor VIIa or Prothrombin Complex Concentrates (PCC) within 48 hours of enrolment, or with known hypercoagulable state
Patients receiving L-asparaginase as part of their current cycle of treatment
History of immune thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS)
Patients with overt disseminated intravascular coagulation (DIC) (See Appendix 3 in the protocol for definition)
Patients requiring a platelet transfusion threshold >10x10/⁹L at time of randomisation. (This refers to patients who require their platelet count to be maintained at a certain specified level on an ongoing basis, and excludes a transient rise in the threshold due to sepsis.)
Patients with a known inherited or acquired bleeding disorder e.g.
1. Acquired storage pool deficiency
2. Paraproteinaemia with platelet inhibition
Patients receiving anticoagulant therapy or anti-platelet therapy
Patients with visible haematuria at time of randomisation
Patients with anuria (defined as urine output < 10 mls/hr over 24 hours).
Patients with severe renal impairment (eGFR ≤30 ml/min/1.73m²)
Patients with a previous history of epilepsy, convulsions, fits or seizures
Patients who are pregnant or breast-feeding
Allergic to tranexamic acid.
Patients enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
Patients previously randomised into this trial at any stage of their treatment.

Name	Affiliation	Role
Lise J Estcourt, MBBChir MSc DPhil MRCP FRCPath	NHS Blood and Transplant	Principal Investigator
Zoe K McQuilten, MBBS PhD	Monash University	Principal Investigator
Simon J Stanworth, DPhil FRCP FRCPath	NHS Blood and Transplant	Principal Investigator
Erica M Wood, MB BS, FRACP, FRCPA	Monash University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Royal Adelaide Hospital		Adelaide			Australia
Royal Brisbane

PubMed Identifier	Type	Citation	Retractions
39642900	Result	TREATT Trial Investigators. Tranexamic acid versus placebo to prevent bleeding in patients with haematological malignancies and severe thrombocytopenia (TREATT): a randomised, double-blind, parallel, phase 3 superiority trial. Lancet Haematol. 2025 Jan;12(1):e14-e22. doi: 10.1016/S2352-3026(24)00317-X. Epub 2024 Dec 3.
31615553	Derived

Label	URL
Published paper- Tranexamic acid versus placebo to prevent bleeding in patients with haematological malignancies and severe thrombocytopenia (TREATT): a randomised, double-blind, parallel, phase 3 superiority trial	View source

ID	Type	URL	Comment
PMC6792262	Study Protocol	View IPD

ID	Title	Description
FG000	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.
FG001	Control Arm

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 30, 2018	Dec 9, 2024

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

1 participant missing this information

Mean

Standard Deviation

years

Title

Denominators

Categories

- ParticipantsBG000309
- ParticipantsBG001306
- ParticipantsBG002615

Title	Measurements

Sex/Gender, Customized

1 participant missing this information

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000309 ParticipantsBG001306 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000310 ParticipantsBG001306 ParticipantsBG002

Height

6 participants missing this information

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG000305 ParticipantsBG001305 ParticipantsBG002

Weight

4 participants missing this information

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG000307 ParticipantsBG001305 ParticipantsBG002

Diagnosis

1 participant missing this information

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000309 ParticipantsBG001306 ParticipantsBG002

Treatment plan

1 participant missing this information

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000309 ParticipantsBG001306 ParticipantsBG002

Platelet count at consent

4 participants missing this information

Mean

Standard Deviation

10^9 cells/L

Title	Denominators	Categories
	ParticipantsBG000309 ParticipantsBG001303 ParticipantsBG002

Platelet count at randomisation

3 participants missing this information

Mean

Standard Deviation

10^9 cells/L

Title	Denominators	Categories
	ParticipantsBG000309 ParticipantsBG001304 ParticipantsBG002

Haemoglobin at consent

5 participants missing this information

Mean

Standard Deviation

G/L

Title	Denominators	Categories
	ParticipantsBG000308 ParticipantsBG001303 ParticipantsBG002

Haemoglobin at randomisation

3 participants missing this information

Mean

Standard Deviation

G/L

Title	Denominators	Categories
	ParticipantsBG000309 ParticipantsBG001304 ParticipantsBG002

FACT-G subscale score at randomisation

Functional Assessment of Cancer Therapy General (FACT-G)

Description: General quality of life instrument intended for use with a variety of chronic illness conditions.

Number of items: 27 (7 for each category, excluding emotional which is 6)

Name of categories/domains: Physical, social/family, emotional, and functional well-being.

Scoring: Subscale scores added to obtain category scores.

Interpretation: A higher total score demonstrates a better quality of life. (Physical, social/family, functional well-being score range: 0-28, Emotional score range: 0-24)

Some participants are missing data for these QOL questionnaires

Mean

Standard Deviation

scores on a scale

Title	Denominators	Categories
Physical well-being	ParticipantsBG000272 ParticipantsBG001

FACT-G total score at randomisation

Functional Assessment of Cancer Therapy General (FACT-G)

Description: General quality of life instrument intended for use with a variety of chronic illness conditions.

Scoring: Category scores added to obtain total score.

Interpretation: A higher total score demonstrates a better quality of life. (FACT-G total score range: 0-108)

76 participants missing this information

Mean

Standard Deviation

scores on a scale

Title	Denominators	Categories
	ParticipantsBG000268 ParticipantsBG001272

FACT-Th total score at randomisation

Functional Assessment of Cancer Therapy - Thrombocytopenia (18-item version) (FACT-Th18)

Objective: To measure the self-reported quality of life (QoL) concerns of patients with thrombocytopenia

Interpretation: A higher total score demonstrates a better quality of life (FACT-Th total score range: 0-180)

79 participants missing this information

Mean

Standard Deviation

scores on a scale

Title	Denominators	Categories
	ParticipantsBG000266 ParticipantsBG001271

Medical history

Some participants are missing data for medical history

Count of Participants

Participants

Title	Denominators	Categories
Diabetes requiring treatment	ParticipantsBG000309 ParticipantsBG001306 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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.

Participants with primary outcome data reported

Posted

Number

95% Confidence Interval

percentage of participants

The first 30 days from first dose of trial treatment

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000298 OG001295

Title

Denominators

Categories

Title	Measurements
	OG00031.7(26.6 to 37.4) OG00134.2(29.0 to 40.0)

Secondary

Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant.

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

Participants with primary outcome data reported

Posted

Mean

Standard Deviation

percentage of days

The first 30 days from first dose of trial treatment .

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

Time to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30.

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.

Participants with primary outcome data reported

Posted

Median

Inter-Quartile Range

Lower quartile for number of days

The first 30 days from first dose of trial treatment.

Days

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants

Secondary

Highest Grade of Bleeding a Patient Experiences up to Study Day 30.

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

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

Posted

Count of Participants

Participants

The first 30 days from first dose of trial treatment.

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants

Secondary

Number of Platelet Transfusions Per Patient up to Study Day 30.

Measured by number of recorded platelet transfusions per patient.

Participants with primary outcome data reported

Posted

Median

Inter-Quartile Range

platelet units

The first 30 days from first dose of trial treatment.

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

Number of Red Cell Transfusions Per Patient up to Study Day 30.

Measured by number of recorded red cell transfusions per patient.

Participants with primary outcome data reported

Posted

Median

Inter-Quartile Range

Red cell units

The first 30 days from first dose of trial treatment.

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

Proportion of Patients Surviving at Least 30 Days Without a Platelet Transfusion.

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

Participants with primary outcome data reported

Posted

Number

95% Confidence Interval

proportion

The first 30 days from first dose of trial treatment.

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

Proportion of Patients Surviving at Least 30 Days Without a Red Cell Transfusion.

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

Participants with primary outcome data reported

Posted

Number

95% Confidence Interval

proportion

The first 30 days from first dose of trial treatment.

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

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)

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

All-cause Mortality During the First 30 Days and 120 Days After the First Dose of Trial Treatment is Administered.

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.

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

Posted

Number

95% Confidence Interval

proportion

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

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

Death Due to Thrombosis During the First 120 Days After the First Dose of Trial Treatment is Administered.

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.

Posted

Number

percent

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

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

Death Due to Bleeding During the First 30 Days After the First Dose of Trial Treatment is Administered.

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

Posted

Number

percent

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

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Secondary

Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered.

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

Posted

Number

Serious adverse events

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

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Other Pre-specified

Proportion of Days With Thrombocytopenia (≤10x10⁹/L, ≤30x10⁹L, ≤50x10⁹/L).

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

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

Posted

Mean

Standard Deviation

Days with thrombocytopenia

Measured during first 30 days from first dose of IMP.

Days a platelet count should be reported

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Other Pre-specified

Reasons for Platelet Transfusions.

Reasons for platelet transfusions as documented by clinician.

Participants with at least one platelet transfusion

Posted

Number

Platelet transfusions

Measured during first 30 days from first dose of IMP.

Number of platelet transfusions

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Other Pre-specified

Reasons for Red Cell Transfusions.

Reasons for red cell transfusions as documented by clinician.

Participants with at least one red cell transfusion

Posted

Number

Red cell transfusions

Measured during first 30 days from first dose of IMP.

Number of red cell transfusions given

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

Other Pre-specified

Proportion of Days With Fever

Highest daily temperature ≥ 38.1°C

Participants with fever data reported

Posted

Mean

Standard Deviation

Days

Measured during first 30 days from first dose of IMP.

Days a temperature should be reported

ID	Title	Description
OG000	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.
OG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets

Units	Counts
Participants	OG000

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	23	300	77	300	8	300
EG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets	14	297	82	297	5	297

Term	Organ System	Assessment Type	Statistical Information
Sepsis (at least one event)	Infections and infestations	Non-systematic Assessment	EG00025 affected300 at risk EG00127 affected297 at risk
Organ Failure (at least one event)	General disorders	Non-systematic Assessment	EG0004 affected300 at risk EG0016 affected297 at risk
GvHD (at least one event)	Immune system disorders	Non-systematic Assessment	EG0005 affected300 at risk EG0017 affected297 at risk
Transfusion reaction (at least one event)	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected300 at risk EG0014 affected297 at risk
Fever (at least one event)	Infections and infestations	Non-systematic Assessment	EG00020 affected300 at risk EG00120 affected297 at risk
Other SAEs (at least one event)	General disorders	Non-systematic Assessment	EG00029 affected300 at risk EG00135 affected297 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Venous thromboembolisms	Vascular disorders		Non-systematic Assessment		EG0007 affected300 at risk EG0014 affected297 at risk
Arterial ischaemic events	Vascular disorders		Non-systematic Assessment		EG0001 affected300 at risk EG0011 affected297 at risk

ID	Term
D019337	Hematologic Neoplasms
D006470	Hemorrhage

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	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.
BG001	Control Arm	Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Placebo: IV (saline) or oral placebo tablets
BG002	Total	Total of all reporting groups

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals