Tranexamic Acid Adverse ReactionNCT05696951
Tranexamic Acid in Sleeve Gastrectomy
A study testing Transamine 200mg iv in people with Tranexamic Acid Adverse Reaction, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effectiveness of Tranexamic acid use will be measured in cases of sleeve gastrectomy in bariatric surgery and in early postoperative bleeding. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tranexamic Acid Adverse Reaction
- What is being tested?
- Transamine 200mg iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 2 Jan 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years with an American Association of Anesthesiologists (ASA) physical condition score II or III
- undergoing bariatric surgery and LSG
Who cannot join
- history of thromboembolic disease or severe comorbidity (ASA IV or more)
- platelet antiaggregants or anticoagulants
- active intravascular coagulation carriers
- acute occlusive vasculopathy
- hypersensitivity to the components of the TXA formula.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Göztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, Istanbul, 34732
About this study
Official title: Use of Tranexamic Acid in Postoperative Early Period Bleeding in Patients Undergoing Sleeve Gastrectomy: A Randomized Controlled Trial
The effectiveness of Tranexamic acid use will be measured in cases of sleeve gastrectomy in bariatric surgery and in early postoperative bleeding.
Read the detailed description
Prospective, comparative and double-blind study with patients aged 18-65 years admitted to bariatric surgery. Selected patients were given or not given venous tranexamic acid (TXA) during anesthesia induction (CG). Anesthesia and thromboprophylaxis protocols were similar between groups. For statistical analysis, χ2 and analysis of variance tests were performed using the SPSS 21.0 ® statistical program at a significance level of p < 0.05.
- Conditions
- Tranexamic Acid Adverse Reaction
- Being tested
- Transamine 200mg iv
- Keywords
- tranexamic acid, Sleeve gastrectomy, Postoperative bleeding
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transamine 200mg ivOther
In the intervention group, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes at the end of the surgery. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) SF. The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| The effectiveness of Tranexamic acid use of sleeve gastrectomy | Active comparator | In this study, it was determined which treatment package would be received by opening the closed envelopes of patients who had at least one point or more bleeding during the operation and had hemostasis with clips. In the intervention group, at the end of the surgery, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) saline. Receives: Other: Transamine 200mg iv |
| Plasebo grup | Placebo comparator | The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours. Receives: Other: Transamine 200mg iv |
| Sham grup | Active comparator | Patients with no bleeding to be treated were not enveloped and were excluded from the intervention or placebo group. Receives: Other: Transamine 200mg iv |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on bleeding in the first one hours postoperatively
postoperative bleeding
Measured: postoperative 1st hours
Secondary outcomes (1)
effect on bleeding in the first 24 hours postoperatively
The effect of tranexamic acid on early postoperative bleeding
Measured: postoperative 24st hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion2 Jan 2023
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 Tranexamic Acid Adverse ReactionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medeni Şermet, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- medeni şermet, 1, Principal investigator, Goztepe Prof Dr Suleyman Yalcın City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696951
- Sponsor's protocol ID
- Bnk723
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sermet M, Ozsoy MS. Effect of Tranexamic Acid on Postoperative Bleeding in Sleeve Gastrectomy: a Randomized Trial. Obes Surg. 2023 Dec;33(12):3962-3970. doi: 10.1007/s11695-023-06902-x. Epub 2023 Oct 19.
PubMed 37857939
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tranexamic Acid in Postoperative Early Period Bleeding in Patients Undergoing Sleeve Gastrectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05696951
- Acronym / sponsor ID
- Bnk723
- Conditions
- Tranexamic Acid Adverse Reaction
- Keywords
- tranexamic acid, Sleeve gastrectomy, Postoperative bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 25 Jan 2023 (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 effectiveness of Tranexamic acid use will be measured in cases of sleeve gastrectomy in bariatric surgery and in early postoperative bleeding.
Detailed description
Prospective, comparative and double-blind study with patients aged 18-65 years admitted to bariatric surgery. Selected patients were given or not given venous tranexamic acid (TXA) during anesthesia induction (CG). Anesthesia and thromboprophylaxis protocols were similar between groups. For statistical analysis, χ2 and analysis of variance tests were performed using the SPSS 21.0 ® statistical program at a significance level of p < 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The effectiveness of Tranexamic acid use of sleeve gastrectomy | Active comparator | Other: Transamine 200mg ivIn this study, it was determined which treatment package would be received by opening the closed envelopes of patients who had at least one point or more bleeding during the operation and had hemostasis with clips. In the intervention group, at the end of the surgery, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) saline. |
| Plasebo grup | Placebo comparator | Other: Transamine 200mg ivThe placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours. |
| Sham grup | Active comparator | Other: Transamine 200mg ivPatients with no bleeding to be treated were not enveloped and were excluded from the intervention or placebo group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 65 years with an American Association of Anesthesiologists (ASA) physical condition score II or III
- undergoing bariatric surgery and LSG
Key exclusion criteria (5 listed)
- history of thromboembolic disease or severe comorbidity (ASA IV or more)
- platelet antiaggregants or anticoagulants
- active intravascular coagulation carriers
- acute occlusive vasculopathy
- hypersensitivity to the components of the TXA formula.
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 |
|---|---|---|
| Transamine 200mg ivIn the intervention group, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes at the end of the surgery. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) SF. The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours. | Other | Plasebo grup, Sham grup, The effectiveness of Tranexamic acid use of sleeve gastrectomy |
Primary outcome
effect on bleeding in the first one hours postoperatively
Time frame: postoperative 1st hours
postoperative bleeding
1 secondary outcome
effect on bleeding in the first 24 hours postoperatively
Time frame: postoperative 24st hours
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 25 Jan 2023.
- Derived from this study: PubMed 37857939Sermet M, Ozsoy MS. Effect of Tranexamic Acid on Postoperative Bleeding in Sleeve Gastrectomy: a Randomized Trial. Obes Surg. 2023 Dec;33(12):3962-3970. doi: 10.1007/s11695-023-06902-x. Epub 2023 Oct 19.
- Individual participant dataSharing planned: No
Related trials for Tranexamic Acid Adverse Reaction
Recruiting
Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery
Blood Coagulation Disorder, Postoperative Blood Loss
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.
medeni şermet, 1 principal investigator
Goztepe Prof Dr Suleyman Yalcın City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transamine 200mg iv in people with Tranexamic Acid Adverse Reaction, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 25 Jan 2023. 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 Turkey (Türkiye). 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.
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?
effect on bleeding in the first one hours postoperatively (time frame: postoperative 1st hours). 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 NCT05696951, 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 25 Jan 2023.