Bronchoscopy BiopsyPhase 2NCT02219152
Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study
A Phase 2 study testing tranexamic acid and saline in people with Bronchoscopy Biopsy, run by Liran Levy at 1 site in Israel.
Trial summary
Bleeding during transbronchial ro endobronchial biopsy is rather a common complication. Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial amount of bleeding that requires a special treatment or follow up. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchoscopy Biopsy
- What is being tested?
- tranexamic acid and saline
- 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 siteIsrael
- Study dates
- Sep 2014to Dec 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient that are candidates to endobronchial or transcronchial biopsy
Who cannot join
- S/P MI or CVA or PE or DVT .
- S/P thrombophilia.
- Patients under coagulation therpay
- Chronic Renal Failure
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Liran Levy, MD, 6475189676, dlev330@hadassah.org.il
About this study
Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.
Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial amount of bleeding that requires a special treatment or follow up.
The goal of this study is to examine whether submission of tranexamic acid during the biopsy could diminish the amount of bleeding.
- Conditions
- Bronchoscopy Biopsy
- Being tested
- tranexamic acid, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acidDrug
salineDrug
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Experimental | tranexamic acid will be administrated using the bronchoscope Receives: Drug: tranexamic acid |
| saline | Placebo comparator | the saline will be administrated using an infusion during the biopsy. Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of bleeding
amount of bleedibg that will be calculated on the basis of the difference between the amount of saline that will be injected at the bronchoscopy and the blood and fluid that will be collected in the suction tank.
Measured: participants will be followed for the duration of hospital stay, an expected average of one day
Secondary outcomes (1)
amount of erythrocytes
amount of erythrocytes by multiplying the Hematocrit and blood volume
Measured: participants will be followed for the duration of hospital stay, an expected average of one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchoscopy BiopsyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liran Levy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liran Levy, Hadassah Medical Organization
- Investigators
- Neville Berkman, MD, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219152
- Sponsor's protocol ID
- 0321-14
- Status last verified
- May 2018
- First submitted
- 12 Aug 2014
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02219152
- Acronym / sponsor ID
- 0321-14
- Conditions
- Bronchoscopy Biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Liran LevyUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Aug 2014 (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.
Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.
Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial amount of bleeding that requires a special treatment or follow up.
The goal of this study is to examine whether submission of tranexamic acid during the biopsy could diminish the amount of bleeding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Experimental | Drug: tranexamic acidtranexamic acid will be administrated using the bronchoscope |
| saline | Placebo comparator | Drug: salinethe saline will be administrated using an infusion during the biopsy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient that are candidates to endobronchial or transcronchial biopsy
Key exclusion criteria (5 listed)
- S/P MI or CVA or PE or DVT .
- S/P thrombophilia.
- Patients under coagulation therpay
- Chronic Renal Failure
- Pregnancy
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 | Drug | tranexamic acid |
| saline | Drug | saline |
Primary outcome
amount of bleeding
Time frame: participants will be followed for the duration of hospital stay, an expected average of one day
amount of bleedibg that will be calculated on the basis of the difference between the amount of saline that will be injected at the bronchoscopy and the blood and fluid that will be collected in the suction tank.
1 secondary outcome
amount of erythrocytes
Time frame: participants will be followed for the duration of hospital stay, an expected average of one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
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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.
Neville Berkman, MD study director
Hadassah Medical Organization
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 tranexamic acid and saline in people with Bronchoscopy Biopsy, run by Liran Levy at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 1 Jun 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liran Levy, MD (6475189676, dlev330@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of bleeding (time frame: participants will be followed for the duration of hospital stay, an expected average of one day). 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 1 Jun 2018.