Bleeding ReductionPhase 4NCT03070847
Low vs. Very Low Dose of Prophylactic Tranexamic Acid for Bleeding Reduction During Rhinoplasty
A Phase 4 study testing Tranexamic Acid and Sodium Chloride in people with Bleeding Reduction, run by Bartłomiej Wódarski at 1 site in Poland.
Trial summary
The purpose of this study is to determine whether very low dose of preoperative tranexamic acid (5mg/kg) is as effective as low dose (10mg/kg) for intraoperational bleeding reduction in patients undergoing elective rhinoplasty surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bleeding Reduction
- What is being tested?
- Tranexamic Acid and Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2017to Mar 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age > 18 y.o.
- American Society of Anesthesiologists Physical Status Classification (ASA) 1-2
- signed informed consent form after reading the information about the study and talking with one of the investigators
Who cannot join
- pregnancy
- known allergies for tranexamic acid or any other substance in Exacyl
- deep vein thrombosis
- Hormone Replacement Therapy or oral contraceptive usage
- anticoagulants usage
- obesity - BMI (body mass index) >30 kg/m2
- renal disease, as glomerular filtration rate (GFR) <60 ml/min/1,73 m*m
- seizures or epilepsy in the past
Trial locations and contacts
1 site in 1 country.
Paweł Krzęczko, MD contact
Poland1 site, 1 recruiting
- Recruiting
Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie
Warsaw, Masovian Voivodeship, 00-416
Bartłomiej Wódarski, MD, 505064789, barwoda@gmail.com
Paweł Krzęczko, MD, pawkrze@o2.pl
About this study
Official title: Impact of Prophylactic Tranexamic Acid on Intra and Postoperational Bleeding Reduction in Patients Undergoing Rhinoplasty Surgery. Low (10mg/kg) and Very Low (5mg/kg) Dose Comparison
The purpose of this study is to determine whether very low dose of preoperative tranexamic acid (5mg/kg) is as effective as low dose (10mg/kg) for intraoperational bleeding reduction in patients undergoing elective rhinoplasty surgery.
Read the detailed description
Background
Tranexamic acid is a drug registered for bleeding prevention and reduction. It is on the World Health Organisation (WHO) 'essential drugs list'. Preoperative tranexamic acid efficacy is well proved for doses between 10 and 40 mg/kg and last years and decades publications showed that 'low dose' (10mg/kg) is as efficient as higher doses but connected with less adverse effects.
Objectives
To determine whether 5 mg/kg dose is as effective as commonly used 10mg/kg dose in intraoperational bleeding reduction.
Methodology All patients would be randomised into one of two arms - low and very low dose. Patients, investigators and caregivers would be blinded. Patients would receive intravenous bolus of tranexamic acid at 15 minutes before admission to operation theatre in a dose dependent on the study arm. General, intravenous anesthesia (total intravenous anesthesia) would be performed due to hospital standards. At the end of the surgery total blood volume and adverse effects would be noted. Surgeon would asses surgical field in the Fromm scale.
The survey is planned for a two years timespan or until 50 patients have enrolled (25 for each arm).
- Conditions
- Bleeding Reduction
- Being tested
- Tranexamic Acid, Sodium Chloride
- Keywords
- tranexamic acid, rhinoplasty, bleeding reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Exacyl
Dose: 5mg/kg
Tranexamic AcidDrug
Also called Exacyl
Dose: 10mg/kg
Sodium ChlorideDrug
Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.
| Study group | Role | What they receive |
|---|---|---|
| Very low dose | Experimental | Will receive single bolus of Tranexamic acid. Dose: 5mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre. Receives: Drug: Tranexamic Acid; Drug: Sodium Chloride |
| Low dose | Active comparator | Will receive single bolus of Tranexamic acid. Dose: 10mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre. Receives: Drug: Tranexamic Acid; Drug: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperational bleeding
it would be assessed at the end of the surgery by measuring blood volume in the suction device and net weight of all surgical material. (precision balance - 2 mg)
Measured: during rhinoplasty
Secondary outcomes (3)
Adverse effects
any adverse effects connected with tranexamic acid usage would be noted
Measured: during rhinoplasty and first day after surgery
surgical field assesment
Fromm scale of surgical field would be used
Measured: during rhinoplasty
surgery length
surgical procedure length would be noted
Measured: during rhinoplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start1 Mar 2017
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding ReductionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartłomiej Wódarski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bartłomiej Wódarski, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070847
- Sponsor's protocol ID
- txa01
- Status last verified
- Aug 2017
- First submitted
- 21 Feb 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prophylactic Tranexamic Acid on Intra and Postoperational Bleeding Reduction in Patients Undergoing Rhinoplasty Surgery. Low (10mg/kg) and Very Low (5mg/kg) Dose Comparison
- ClinicalTrials.gov ID
- NCT03070847
- Acronym / sponsor ID
- txa01
- Conditions
- Bleeding Reduction
- Keywords
- tranexamic acid, rhinoplasty, bleeding reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bartłomiej WódarskiUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 6 Mar 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 purpose of this study is to determine whether very low dose of preoperative tranexamic acid (5mg/kg) is as effective as low dose (10mg/kg) for intraoperational bleeding reduction in patients undergoing elective rhinoplasty surgery.
Detailed description
Background
Tranexamic acid is a drug registered for bleeding prevention and reduction. It is on the World Health Organisation (WHO) 'essential drugs list'. Preoperative tranexamic acid efficacy is well proved for doses between 10 and 40 mg/kg and last years and decades publications showed that 'low dose' (10mg/kg) is as efficient as higher doses but connected with less adverse effects.
Objectives
To determine whether 5 mg/kg dose is as effective as commonly used 10mg/kg dose in intraoperational bleeding reduction.
Methodology All patients would be randomised into one of two arms - low and very low dose. Patients, investigators and caregivers would be blinded. Patients would receive intravenous bolus of tranexamic acid at 15 minutes before admission to operation theatre in a dose dependent on the study arm. General, intravenous anesthesia (total intravenous anesthesia) would be performed due to hospital standards. At the end of the surgery total blood volume and adverse effects would be noted. Surgeon would asses surgical field in the Fromm scale.
The survey is planned for a two years timespan or until 50 patients have enrolled (25 for each arm).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low dose | Experimental | Drug: Tranexamic Acid, Drug: Sodium ChlorideWill receive single bolus of Tranexamic acid. Dose: 5mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre. |
| Low dose | Active comparator | Drug: Tranexamic Acid, Drug: Sodium ChlorideWill receive single bolus of Tranexamic acid. Dose: 10mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age > 18 y.o.
- American Society of Anesthesiologists Physical Status Classification (ASA) 1-2
- signed informed consent form after reading the information about the study and talking with one of the investigators
Key exclusion criteria (8 listed)
- pregnancy
- known allergies for tranexamic acid or any other substance in Exacyl
- deep vein thrombosis
- Hormone Replacement Therapy or oral contraceptive usage
- anticoagulants usage
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: ExacylDose: 5mg/kg | Drug | Very low dose |
| Tranexamic AcidAlso: ExacylDose: 10mg/kg | Drug | Low dose |
| Sodium ChlorideTranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml. | Drug | Low dose, Very low dose |
Primary outcome
Intraoperational bleeding
Time frame: during rhinoplasty
it would be assessed at the end of the surgery by measuring blood volume in the suction device and net weight of all surgical material. (precision balance - 2 mg)
3 secondary outcomes
Adverse effects
Time frame: during rhinoplasty and first day after surgery
surgical field assesment
Time frame: during rhinoplasty
surgery length
Time frame: during rhinoplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- 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.
Paweł Krzęczko, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid and Sodium Chloride in people with Bleeding Reduction, run by Bartłomiej Wódarski at 1 site in Poland.
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 8 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: status not confirmed, as of the sponsor's last update on 30 Aug 2017. 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 Poland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bartłomiej Wódarski, MD (505064789, barwoda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperational bleeding (time frame: during rhinoplasty). 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 30 Aug 2017.