BleedingPhase 4BleedingNCT04224116
Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery
A Phase 4 study testing Tranexamic acid injection and SSI in people with Bleeding, run by University Tunis El Manar.
Trial summary
Bleeding after thoracic surgery is a major cause of perioperative hemodynamic instability and transfusion requirement, which can lead to a rise of morbidity, mortality and costs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bleeding
- What is being tested?
- Tranexamic acid injection and SSI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 2 Oct 2019
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux.
Who cannot join
- Patients who have had a major complication of surgery other than bleeding requiring revision within 24 hours or a complication related to anesthesia, and cases of non-compliance with the anesthetic protocol are excluded.
About this study
Official title: Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery
Bleeding after thoracic surgery is a major cause of perioperative hemodynamic instability and transfusion requirement, which can lead to a rise of morbidity, mortality and costs.
The objective of this study is to evaluate the efficiency of tranexamic acid (TA) in the prevention of perioperative bleeding in thoracic hemorrhagic surgery.
Read the detailed description
It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified.
Two groups of patients:
- TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
- Serum saline isotonic (SSI) group: placebo with isotonic saline serum.
- Conditions
- Bleeding
- Being tested
- Tranexamic acid injection, SSI
- Keywords
- tranexamic acid, Antifibrinolytic agents, bleeding, blood transfusion, thoracic surgery.
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Also called EXACYL
to receive tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
SSIDrug
Also called placebo
Serum Salin isotonic injected
| Study group | Role | What they receive |
|---|---|---|
| Group TA | Experimental | receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. Receives: Drug: Tranexamic acid injection |
| Group SSI | Placebo comparator | Serum saline isotonic (SSI) group: placebo with isotonic saline serum. Receives: Drug: SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative bleeding volume
The blood volume collected in the suction tanks and the operative drapes intraoperatively
Measured: five hours
Secondary outcomes (2)
The number of red globular caps transfused for each group
transfusion if hemoglobin less than 7 g / dl
Measured: one month
bleeding volume in the thoracic drains postoperatively
bleeding volume in the thoracic drains postoperatively every day
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jan 2014
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified. Two groups of patients: * TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. * Serum saline isotonic (SSI) group: placebo with isotonic saline serum.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Ben Haj Youssef, University Tunis El Manar
- Investigators
- Tahar Mestiri, Professor, Principal investigator, university Manar Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224116
- Sponsor's protocol ID
- TA
- Acronym
- Bleeding
- Status last verified
- Jan 2020
- First submitted
- 1 Oct 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery
- ClinicalTrials.gov ID
- NCT04224116
- Acronym / sponsor ID
- Bleeding / TA
- Conditions
- Bleeding
- Keywords
- tranexamic acid, Antifibrinolytic agents, bleeding, blood transfusion, thoracic surgery.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 13 Jan 2020 (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.
Bleeding after thoracic surgery is a major cause of perioperative hemodynamic instability and transfusion requirement, which can lead to a rise of morbidity, mortality and costs.
The objective of this study is to evaluate the efficiency of tranexamic acid (TA) in the prevention of perioperative bleeding in thoracic hemorrhagic surgery.
Detailed description
It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified.
Two groups of patients:
- TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
- Serum saline isotonic (SSI) group: placebo with isotonic saline serum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified. Two groups of patients: * TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. * Serum saline isotonic (SSI) group: placebo with isotonic saline serum.
| Arm | Type | Receives |
|---|---|---|
| Group TA | Experimental | Drug: Tranexamic acid injectionreceiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. |
| Group SSI | Placebo comparator | Drug: SSISerum saline isotonic (SSI) group: placebo with isotonic saline serum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux.
Key exclusion criteria (1 listed)
- Patients who have had a major complication of surgery other than bleeding requiring revision within 24 hours or a complication related to anesthesia, and cases of non-compliance with the anesthetic protocol are excluded.
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 injectionAlso: EXACYLto receive tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. | Drug | Group TA |
| SSIAlso: placeboSerum Salin isotonic injected | Drug | Group SSI |
Primary outcome
intraoperative bleeding volume
Time frame: five hours
The blood volume collected in the suction tanks and the operative drapes intraoperatively
2 secondary outcomes
The number of red globular caps transfused for each group
Time frame: one month
bleeding volume in the thoracic drains postoperatively
Time frame: one 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 13 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Tahar Mestiri, Professor principal investigator
university Manar Tunis
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid injection and SSI in people with Bleeding, run by University Tunis El Manar.
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 13 Jan 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
intraoperative bleeding volume (time frame: five 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 13 Jan 2020.