Cerebral PalsyPhase 3TABLONCT07672158
Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy
A Phase 3 study testing Tranexamic Acid (IV) in people with Cerebral Palsy and Hip Surgery Corrective, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a clinical trial of postoperative tranexamic acid vs placebo in non-ambulatory children with cerebral palsy (CP) undergoing reconstructive hip surgery. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cerebral Palsy, Hip Surgery Corrective, Tranexamic Acid Use
- What is being tested?
- Tranexamic Acid (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2026to Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (aged 4 to 16 years)
- Diagnosis of cerebral palsy (CP). CP is an umbrella term under which many specific diagnoses are captured, and the clinical team at the study institution operates a comprehensive referral network to ensure patients with any relevant diagnoses are included.
- Gross Motor Function Classification System (GMFCS) levels IV and V, with substantial hip displacement (>40% migration percentage per Australian Hip Surveillance Guidelines (Wynter M, Gibson N, Kentish M, Love S, Thomason P, Willoughby K, et al. Australian hip surveillance guidelines for children with cerebral palsy 2014. Australian Academy of Cerebral Palsy and Developmental Medicine. 2014.)), who are on the waitlist for bilateral proximal femoral varus derotational osteotomy (VDRO) +/- unilateral or bilateral pelvic osteotomy.
Who cannot join
- Haematological disorder (defined as an active genetic or acquired bleeding disorder)
- Known hypersensitivity to tranexamic acid (TXA)
- Children with promyelocytic leukaemia being treated with oral tretinoin will be excluded from the trial because combination with TXA has resulted in fatal thrombotic complications
- Known coagulation defect
- Known renal disorder (moderate to severe as per study institution guidelines)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postoperative Continuous Intravenous Tranexamic Acid Infusion to Reduce Blood Loss in Non-Ambulatory Children With Cerebral Palsy Following Bilateral Bony Hip Reconstructive Surgery: A Phase III Parallel-Group Randomised Placebo-Controlled Trial
TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a clinical trial of postoperative tranexamic acid vs placebo in non-ambulatory children with cerebral palsy (CP) undergoing reconstructive hip surgery.
Improving surgical outcomes is a high priority in this patient population given the high risk of bleeding and the diminished capacity for these children to withstand substantial blood loss. Preliminary data from the study institution indicates that approximately one third of these patients receive transfusion of blood products in the postoperative period. There is growing evidence that hidden blood loss occurring in the postoperative period is substantial and can potentially be attenuated with the administration of Tranexamic Acid (TXA). However, trials on postoperative TXA have been carried out exclusively in adult surgical populations.
Read the detailed description
TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a parallel-group randomised placebo-controlled trial of postoperative tranexamic acid vs placebo in children with CP undergoing bilateral varus derotational osteotomy (VDRO) surgery. The allocation ratio is 1:1 (placebo: intervention), and the trial will be powered to detect a difference in postoperative blood loss calculated using a haemoglobin mass loss formula. Improving perioperative outcomes is a high priority in this patient population given the high risk of bleeding from this surgical intervention and the reduced physiological reserve in these children. Preliminary data from the study institution indicates that approximately one third of these patients receive transfusion of blood products in the postoperative period. There is growing evidence that hidden blood loss occurring in the postoperative period is substantial and can potentially be attenuated with the administration of Tranexamic Acid (TXA). However, trials on postoperative TXA have been carried out exclusively in adult surgical populations. This is an embedded superiority randomised placebo-controlled patient-/treating team-/assessor-blinded trial comparing tranexamic acid with placebo in reducing blood loss following bilateral bony hip reconstructive surgery in non-ambulatory children with cerebral palsy. Primary objective: to evaluate the impact of postoperative continuous intravenous TXA infusion, compared with placebo in the form of normal saline, on blood loss in non-ambulatory children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy. Secondary objectives: to investigate the safety and tolerability of postoperative tranexamic acid in children with CP undergoing bilateral VDRO surgery with or without pelvic osteotomy, and to evaluate the health economic impact of postoperative tranexamic acid in children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy. To the best of the study team's knowledge this will be the first randomised controlled trial to investigate postoperative intravenous TXA in a paediatric surgical population. Trial population: Non-ambulant children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy. Planned sample size is 52 participants (26 in each group: placebo and intervention). Study setting: Single site electronic medical record (EMR) embedded trial in the software platform EpicTM at The Royal Children's Hospital (RCH). Trial intervention: after cessation of the intraoperative tranexamic acid infusion, and once the patient has been transferred to the recovery bay, the postoperative infusion will commence comprising 10mg/kg/hr intravenous TXA for 24 hours. Placebo: equivalent volume of visually identical normal saline will be infused at the same rate as the TXA. Recruitment: It is anticipated that recruitment will commence in June 2026 and cease August 2028, with the last participant completing 6-month follow up period by April 2029. Participant duration: It is anticipated that duration of participation will be approximately four to six months. The time between initial identification as potentially eligible to date of surgery is three months maximum, length of stay is approximately seven days, and post-operative follow-up is 6 months.
- Conditions
- Cerebral Palsy, Hip Surgery Corrective, Tranexamic Acid Use, Blood Loss, Surgical, Paediatrics, Orthopedics
- Being tested
- Tranexamic Acid (IV), Placebo
- Keywords
- Cerebral Palsy, Hip surgery, Tranexamic Acid, Blood Loss, Orthopaedics
- Medical subject headings
- Cerebral Palsy, Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (IV)Drug
Once the patient has been transferred to recovery after surgery, the postoperative infusion will commence comprising 10mg/kg/hr intravenous tranexamic acid for 24 hours.
PlaceboDrug
The control group will receive placebo in the form of normal saline. The volume administered will be identical to that of TXA intervention arm, and the infusion rate will be the same.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid postoperative continuous infusion arm | Experimental | Once the patient has been transferred to recovery after surgery, the postoperative infusion will commence comprising 10mg/kg/hr intravenous tranexamic acid for 24 hours. Receives: Drug: Tranexamic Acid (IV) |
| Normal saline postoperative continuous infusion arm | Placebo comparator | The control group will receive placebo in the form of normal saline, which is physically identical to tranexamic acid and has been used in previous randomised placebo-controlled trials of tranexamic acid. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change between treatment arms in postoperative haemoglobin mass loss, measured on postoperative day 5 or day of discharge (whichever is earlier) and estimated using the HAEmoglobin Mass loss DuRing the periOperative Period (HAEMDROP) formula
HAEMDROP formula:
mHb_loss = BV*(Hb_initial - Hb_final) + (TV * 200), where:
- mHb_loss = Haemoglobin (Hb) mass loss in grams (g)
- BV = Blood volume of the patient in litres (L). For paediatric patients, blood volume is ~75ml/kg.
- Hb_initial = Hb at the start of the period of interest (in grams per litre (g/L)).
- Hb_final = Hb at the end of the period of interest (in grams per litre (g/L)).
- VT = volume (in L) of packed red blood cells transfused between Hb_initial and Hb_final.
- - 200 = 200g/L, the average haemoglobin level in a unit of blood. Multiplying this by the VT gives the haemoglobin mass transfused (in grams)
Measured: Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)
Secondary outcomes (9)
Number of clinically significant seizures
Seizures experienced between Day of surgery until Day 5 post-operatively which:
- are more frequent or more severe than the participant's pre-admission baseline.
- necessitate additional clinical monitoring or intervention, as per institutional guidelines, beyond what is expected from the participant's pre-admission baseline seizure management.
- seizures which require the administration of rescue medications which deviates from what is typical for the participant at baseline.
Measured: Day of surgery until Day 5 post-operatively
Duration of hospital stay
Total duration of hospital stay, in calendar days, from date of admission (= day zero) to date of discharge.
Measured: Date of surgery, date of discharge from hospital which will be an anticipated average of 8.28 days
Duration of paediatric intensive care unit admission
The occurrence and duration of both planned and unplanned admission to the paediatric intensive care (PICU) unit during the participant's post-operative inpatient period.
Measured: Date of PICU admission through to date of discharge from PICU which will be an anticipated average of 26.5 hours
Volume of packed red blood cells transfused
Volume of packed red blood cells transfused during the period over which the primary outcome is measured (from end of operation to postoperative day 5 inclusive).
Measured: From end of operation to postoperative day 5 or day of discharge (whichever comes first)
Incidence of surgical wound infections - superficial incisional surgical site infection
Surgical site infection event defined in accordance with the Centers for Disease Control and Prevention (CDC)'s National Healthcare Safety Network (NHSN) criteria
Measured: Day of surgery through to 30 days following surgery
Incidence of surgical wound infections - deep incisional surgical site infection
Surgical site infection event defined in accordance with the Centers for Disease Control and Prevention (CDC)'s National Healthcare Safety Network (NHSN) criteria
Measured: Day of surgery through to 90 days following surgery
Incidence of venous thromboembolism events requiring treatment
Incidence of venous thromboembolism requiring anticoagulant treatment in accordance with study institution guidelines will be captured.
Measured: Day of surgery through to Day 5 post-surgery
Changes in in quality of life, measured in quality-adjusted life years (QALYs)
The EuroQol 5 dimensions (EQ-5D) by proxy will be completed by participants' parent/guardian. The EQ-5D is numbered from 0 to 100, where 100 means the best health you can imagine and 0 means the worst health you can imagine. From this, QALYs will be calculated and compared between intervention and control groups.
Measured: Preoperatively, 3 months postoperatively, 6 months postoperatively
Changes in quality of life
Changes in quality of life will be captured by the CP-CHILD (caregiver) questionnaire, which measures:
Social wellbeing \& acceptance, Feelings about functioning, Participation \& physical health, Emotional wellbeing \& self-esteem, Access to services, Pain \& impact of disability, Family health
Measured: Preoperatively, 3 months postoperatively, 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, Royal Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Erich Rutz, MD, PhD, Principal investigator, The University of Melbourne Department of Paediatrics (Orthopaedics), The Royal Children's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672158
- Sponsor's protocol ID
- tablotrialvdrocprchmcri2025123
- Acronym
- TABLO
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised data set collected for the analysis of this trial will be made available 12 months following analysis and publication of the primary outcome. This includes data collected for the primary outcome and each secondary outcome.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Continuous Intravenous Tranexamic Acid Infusion to Reduce Blood Loss in Non-Ambulatory Children With Cerebral Palsy Following Bilateral Bony Hip Reconstructive Surgery: A Phase III Parallel-Group Randomised Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07672158
- Acronym / sponsor ID
- TABLO / tablotrialvdrocprchmcri2025123
- Conditions
- Cerebral Palsy, Hip Surgery Corrective, Tranexamic Acid Use, Blood Loss, Surgical, Paediatrics, Orthopedics
- Keywords
- Cerebral Palsy, Hip surgery, Tranexamic Acid, Blood Loss, Orthopaedics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- University of Melbourne, Royal Children's Hospital
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a clinical trial of postoperative tranexamic acid vs placebo in non-ambulatory children with cerebral palsy (CP) undergoing reconstructive hip surgery.
Improving surgical outcomes is a high priority in this patient population given the high risk of bleeding and the diminished capacity for these children to withstand substantial blood loss. Preliminary data from the study institution indicates that approximately one third of these patients receive transfusion of blood products in the postoperative period. There is growing evidence that hidden blood loss occurring in the postoperative period is substantial and can potentially be attenuated with the administration of Tranexamic Acid (TXA). However, trials on postoperative TXA have been carried out exclusively in adult surgical populations.
Detailed description
TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a parallel-group randomised placebo-controlled trial of postoperative tranexamic acid vs placebo in children with CP undergoing bilateral varus derotational osteotomy (VDRO) surgery. The allocation ratio is 1:1 (placebo: intervention), and the trial will be powered to detect a difference in postoperative blood loss calculated using a haemoglobin mass loss formula. Improving perioperative outcomes is a high priority in this patient population given the high risk of bleeding from this surgical intervention and the reduced physiological reserve in these children. Preliminary data from the study institution indicates that approximately one third of these patients receive transfusion of blood products in the postoperative period. There is growing evidence that hidden blood loss occurring in the postoperative period is substantial and can potentially be attenuated with the administration of Tranexamic Acid (TXA). However, trials on postoperative TXA have been carried out exclusively in adult surgical populations. This is an embedded superiority randomised placebo-controlled patient-/treating team-/assessor-blinded trial comparing tranexamic acid with placebo in reducing blood loss following bilateral bony hip reconstructive surgery in non-ambulatory children with cerebral palsy. Primary objective: to evaluate the impact of postoperative continuous intravenous TXA infusion, compared with placebo in the form of normal saline, on blood loss in non-ambulatory children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy. Secondary objectives: to investigate the safety and tolerability of postoperative tranexamic acid in children with CP undergoing bilateral VDRO surgery with or without pelvic osteotomy, and to evaluate the health economic impact of postoperative tranexamic acid in children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy. To the best of the study team's knowledge this will be the first randomised controlled trial to investigate postoperative intravenous TXA in a paediatric surgical population. Trial population: Non-ambulant children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy. Planned sample size is 52 participants (26 in each group: placebo and intervention). Study setting: Single site electronic medical record (EMR) embedded trial in the software platform EpicTM at The Royal Children's Hospital (RCH). Trial intervention: after cessation of the intraoperative tranexamic acid infusion, and once the patient has been transferred to the recovery bay, the postoperative infusion will commence comprising 10mg/kg/hr intravenous TXA for 24 hours. Placebo: equivalent volume of visually identical normal saline will be infused at the same rate as the TXA. Recruitment: It is anticipated that recruitment will commence in June 2026 and cease August 2028, with the last participant completing 6-month follow up period by April 2029. Participant duration: It is anticipated that duration of participation will be approximately four to six months. The time between initial identification as potentially eligible to date of surgery is three months maximum, length of stay is approximately seven days, and post-operative follow-up is 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid postoperative continuous infusion arm | Experimental | Drug: Tranexamic Acid (IV)Once the patient has been transferred to recovery after surgery, the postoperative infusion will commence comprising 10mg/kg/hr intravenous tranexamic acid for 24 hours. |
| Normal saline postoperative continuous infusion arm | Placebo comparator | Drug: PlaceboThe control group will receive placebo in the form of normal saline, which is physically identical to tranexamic acid and has been used in previous randomised placebo-controlled trials of tranexamic acid. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children (aged 4 to 16 years)
- Diagnosis of cerebral palsy (CP). CP is an umbrella term under which many specific diagnoses are captured, and the clinical team at the study institution operates a comprehensive referral network to ensure patients with any relevant diagnoses are included.
- Gross Motor Function Classification System (GMFCS) levels IV and V, with substantial hip displacement (>40% migration percentage per Australian Hip Surveillance Guidelines (Wynter M, Gibson N, Kentish M, Love S, Thomason P, Willoughby K, et al. Australian hip surveillance guidelines for children with cerebral palsy 2014. Australian Academy of Cerebral Palsy and Developmental Medicine. 2014.)), who are on the waitlist for bilateral proximal femoral varus derotational osteotomy (VDRO) +/- unilateral or bilateral pelvic osteotomy.
Key exclusion criteria (5 listed)
- Haematological disorder (defined as an active genetic or acquired bleeding disorder)
- Known hypersensitivity to tranexamic acid (TXA)
- Children with promyelocytic leukaemia being treated with oral tretinoin will be excluded from the trial because combination with TXA has resulted in fatal thrombotic complications
- Known coagulation defect
- Known renal disorder (moderate to severe as per study institution guidelines)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (IV)Once the patient has been transferred to recovery after surgery, the postoperative infusion will commence comprising 10mg/kg/hr intravenous tranexamic acid for 24 hours. | Drug | Tranexamic acid postoperative continuous infusion arm |
| PlaceboThe control group will receive placebo in the form of normal saline. The volume administered will be identical to that of TXA intervention arm, and the infusion rate will be the same. | Drug | Normal saline postoperative continuous infusion arm |
Primary outcome
Mean change between treatment arms in postoperative haemoglobin mass loss, measured on postoperative day 5 or day of discharge (whichever is earlier) and estimated using the HAEmoglobin Mass loss DuRing the periOperative Period (HAEMDROP) formula
Time frame: Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)
HAEMDROP formula: mHb_loss = BV*(Hb_initial - Hb_final) + (TV * 200), where: * mHb_loss = Haemoglobin (Hb) mass loss in grams (g) * BV = Blood volume of the patient in litres (L). For paediatric patients, blood volume is ~75ml/kg. * Hb_initial = Hb at the start of the period of interest (in grams per litre (g/L)). * Hb_final = Hb at the end of the period of interest (in grams per litre (g/L)). * VT = volume (in L) of packed red blood cells transfused between Hb_initial and Hb_final. * - 200 = 200g/L, the average haemoglobin level in a unit of blood. Multiplying this by the VT gives the haemoglobin mass transfused (in grams)
9 secondary outcomes
Number of clinically significant seizures
Time frame: Day of surgery until Day 5 post-operatively
Duration of hospital stay
Time frame: Date of surgery, date of discharge from hospital which will be an anticipated average of 8.28 days
Duration of paediatric intensive care unit admission
Time frame: Date of PICU admission through to date of discharge from PICU which will be an anticipated average of 26.5 hours
Volume of packed red blood cells transfused
Time frame: From end of operation to postoperative day 5 or day of discharge (whichever comes first)
Incidence of surgical wound infections - superficial incisional surgical site infection
Time frame: Day of surgery through to 30 days following surgery
Incidence of surgical wound infections - deep incisional surgical site infection
Time frame: Day of surgery through to 90 days following surgery
Incidence of venous thromboembolism events requiring treatment
Time frame: Day of surgery through to Day 5 post-surgery
Changes in in quality of life, measured in quality-adjusted life years (QALYs)
Time frame: Preoperatively, 3 months postoperatively, 6 months postoperatively
Changes in quality of life
Time frame: Preoperatively, 3 months postoperatively, 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. The anonymised data set collected for the analysis of this trial will be made available 12 months following analysis and publication of the primary outcome. This includes data collected for the primary outcome and each secondary outcome.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erich Rutz, MD, PhD principal investigator
The University of Melbourne Department of Paediatrics (Orthopaedics), The Royal Children's Hospital Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid (IV) in people with Cerebral Palsy and Hip Surgery Corrective, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erich Rutz, MD, PhD (+61 9345 7645, erich.rutz@rch.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change between treatment arms in postoperative haemoglobin mass loss, measured on postoperative day 5 or day of discharge (whichever is earlier) and estimated using the HAEmoglobin Mass loss DuRing the periOperative Period (HAEMDROP) formula (time frame: Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.