Postoperative HemorrhagePhase 2NCT03244423
Tranexamic Acid in Cyanotic Heart Defects
A Phase 2 study testing Normal saline at induction, Normal saline infusion and Intravenous tranexamic acid in people with Postoperative Hemorrhage, run by Assiut University at 1 site in Egypt.
Trial summary
The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Postoperative Hemorrhage
- What is being tested?
- Normal saline at induction, Normal saline infusion and Intravenous tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2009to Aug 2017
- Phase
- Phase 2
- 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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass
Who cannot join
- Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction within the last 7 days before surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid in Cyanotic Heart Defects: a Risk-benefit Analysis.
The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies
Read the detailed description
40 patients in each one of the three groups; In control group will receive normal saline, Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1 mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic poured into the pericoredial cavity. in the first 24 hours we will measure the total blood loss and transfusion requirements. Complate blood picture and coagulation studies will be recorded. the occurrence of re-exploration for excess bleeding, or adverse events.
- Conditions
- Postoperative Hemorrhage
- Being tested
- Normal saline at induction, Normal saline infusion, Intravenous tranexamic acid, infusion tranexamic acid, topical tranexamic acid
- Keywords
- Pediatric, Cyanotic heart disease, Tranexamic acid, Postoperative blood loss
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline at inductionDrug
0.5 ml/kg
Normal saline infusionDrug
1ml/kg/hr. during surgery for six hours
Intravenous tranexamic acidDrug
50 mg/kg
infusion tranexamic acidDrug
1mg/kg/hr infusionfor 6 hours
topical tranexamic acidDrug
50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure
topical normal salineDrug
2 ml/kg into the pericardial cavity before sternal closure
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | In control group will receive normal saline, Receives: Drug: Normal saline at induction; Drug: Normal saline infusion; Drug: topical normal saline |
| Group 2 | Active comparator | Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours Receives: Drug: Intravenous tranexamic acid; Drug: infusion tranexamic acid; Drug: topical normal saline |
| Group 3 | Active comparator | the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure. Receives: Drug: Normal saline at induction; Drug: Normal saline infusion; Drug: topical tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative blood loss
Blood loss will be measured within first 24 hr.
Measured: within the first 24 hours
Secondary outcomes (3)
total blood transfusion
ml/kg
Measured: within the first 24 hours
the interval from protamine to skin closure
the interval from protamine to skin closure
Measured: within the first 24 hours
the length of ICU stay
by days
Measured: within the first month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study startJan 2009
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- Sayed k Abd-Elshafy, MD, Principal investigator, Associate profossor of anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244423
- Sponsor's protocol ID
- IRB0000879560
- Status last verified
- Jan 2018
- First submitted
- 7 Aug 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: UNDECIDED
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Cyanotic Heart Defects: a Risk-benefit Analysis.
- ClinicalTrials.gov ID
- NCT03244423
- Acronym / sponsor ID
- IRB0000879560
- Conditions
- Postoperative Hemorrhage
- Keywords
- Pediatric, Cyanotic heart disease, Tranexamic acid, Postoperative blood loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Aug 2017 (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.
The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies
Detailed description
40 patients in each one of the three groups; In control group will receive normal saline, Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1 mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic poured into the pericoredial cavity. in the first 24 hours we will measure the total blood loss and transfusion requirements. Complate blood picture and coagulation studies will be recorded. the occurrence of re-exploration for excess bleeding, or adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: Normal saline at induction, Drug: Normal saline infusion, Drug: topical normal salineIn control group will receive normal saline, |
| Group 2 | Active comparator | Drug: Intravenous tranexamic acid, Drug: infusion tranexamic acid, Drug: topical normal salineIntravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours |
| Group 3 | Active comparator | Drug: Normal saline at induction, Drug: Normal saline infusion, Drug: topical tranexamic acidthe topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass
Key exclusion criteria (1 listed)
- Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction within the last 7 days before surgery.
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 |
|---|---|---|
| Normal saline at induction0.5 ml/kg | Drug | Group 1, Group 3 |
| Normal saline infusion1ml/kg/hr. during surgery for six hours | Drug | Group 1, Group 3 |
| Intravenous tranexamic acid50 mg/kg | Drug | Group 2 |
| infusion tranexamic acid1mg/kg/hr infusionfor 6 hours | Drug | Group 2 |
| topical tranexamic acid50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure | Drug | Group 3 |
| topical normal saline2 ml/kg into the pericardial cavity before sternal closure | Drug | Group 1, Group 2 |
Primary outcome
postoperative blood loss
Time frame: within the first 24 hours
Blood loss will be measured within first 24 hr.
3 secondary outcomes
total blood transfusion
Time frame: within the first 24 hours
the interval from protamine to skin closure
Time frame: within the first 24 hours
the length of ICU stay
Time frame: within the first month
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 31 Jan 2018.
- Individual participant dataSharing planned: Undecided. UNDECIDED
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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.
Sayed k Abd-Elshafy, MD principal investigator
Associate profossor of anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normal saline at induction, Normal saline infusion and Intravenous tranexamic acid in people with Postoperative Hemorrhage, run by Assiut University at 1 site in Egypt.
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 1 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 31 Jan 2018. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative blood loss (time frame: within the first 24 hours). 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 31 Jan 2018.