Blood LossTXANCT00994994
Tranexamic Acid in Pediatric Cardiac Surgery
A study testing Tranexamic Acid in people with Blood Loss and Congenital Heart Disease, run by Okayama University.
Trial summary
Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Blood Loss, Congenital Heart Disease
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children undergoing elective cardiac surgery with cardiopulmonary bypass
Who cannot join
- neonate born within 1 month
- preoperative inotropes
- preoperative mechanical ventilation
- preexisting coagulation disorder
- reoperation within 48 hours
- significant liver or kidney disease
- known allergy to TXA
About this study
Official title: Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery
Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.
- Conditions
- Blood Loss, Congenital Heart Disease
- Being tested
- Tranexamic Acid
- Keywords
- pediatric cardiac surgery, bleeding, tranexamic acid, fibrinolysis, blood loss in pediatric cardiac surgery
- Medical subject headings
- Hemorrhage, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called transamine, antifibrinolytic, lysin analogue
50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | 50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit. Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | same volume of normal saline was given. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery
Measured: 24 hours after surgery
Secondary outcomes (8)
blood loss 6 hours after surgery
Measured: 6 hours after surgery
the amount of blood transfusion
Measured: 24 hour after surgery
additional TXA administration
Measured: 24 hours after surgery
chest closure time (protamine to skin closure)
Measured: at the end of surgery
re-exploration of chest for excess bleeding
Measured: within 24 hours after surgery
duration of mechanical ventilation
Measured: at the time of extubation
length of stay in intensive care unit
Measured: at the time of discharge from ICU
episode of thrombotic complication
Measured: from drug administration to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJan 2006
- Primary completionAug 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Investigators
- Yuichiro Toda, MD, PhD, Principal investigator, Department of Anesthesiology and Intensive Care, Okayama University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994994
- Sponsor's protocol ID
- Ped Txa Cya
- Acronym
- TXA
- Status last verified
- Oct 2009
- First submitted
- 13 Oct 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shimizu K, Toda Y, Iwasaki T, Takeuchi M, Morimatsu H, Egi M, Suemori T, Suzuki S, Morita K, Sano S. Effect of tranexamic acid on blood loss in pediatric cardiac surgery: a randomized trial. J Anesth. 2011 Dec;25(6):823-30. doi: 10.1007/s00540-011-1235-z. Epub 2011 Sep 24.
PubMed 21947753
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00994994
- Acronym / sponsor ID
- TXA / Ped Txa Cya
- Conditions
- Blood Loss, Congenital Heart Disease
- Keywords
- pediatric cardiac surgery, bleeding, tranexamic acid, fibrinolysis, blood loss in pediatric cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Oct 2009 (estimated)
- 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.
Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic Acid50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit. |
| Placebo | Placebo comparator | Drug: Tranexamic Acidsame volume of normal saline was given. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children undergoing elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (7 listed)
- neonate born within 1 month
- preoperative inotropes
- preoperative mechanical ventilation
- preexisting coagulation disorder
- reoperation within 48 hours
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 AcidAlso: transamine, antifibrinolytic, lysin analogue50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group. | Drug | Placebo, Tranexamic acid |
Primary outcome
the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery
Time frame: 24 hours after surgery
8 secondary outcomes
blood loss 6 hours after surgery
Time frame: 6 hours after surgery
the amount of blood transfusion
Time frame: 24 hour after surgery
additional TXA administration
Time frame: 24 hours after surgery
chest closure time (protamine to skin closure)
Time frame: at the end of surgery
re-exploration of chest for excess bleeding
Time frame: within 24 hours after surgery
duration of mechanical ventilation
Time frame: at the time of extubation
length of stay in intensive care unit
Time frame: at the time of discharge from ICU
episode of thrombotic complication
Time frame: from drug administration to hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Derived from this study: PubMed 21947753Shimizu K, Toda Y, Iwasaki T, Takeuchi M, Morimatsu H, Egi M, Suemori T, Suzuki S, Morita K, Sano S. Effect of tranexamic acid on blood loss in pediatric cardiac surgery: a randomized trial. J Anesth. 2011 Dec;25(6):823-30. doi: 10.1007/s00540-011-1235-z. Epub 2011 Sep 24.
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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. This study is not recruiting at the moment.
Yuichiro Toda, MD, PhD principal investigator
Department of Anesthesiology and Intensive Care, Okayama University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid in people with Blood Loss and Congenital Heart Disease, run by Okayama University.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994994, which also lists 1 linked publication.
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 2009.