Bronchoscopic Intratumoral injection of Tranexamic Acid for prevention of excessive bleeding during multiple forceps biopsy procedure
| ISRCTN | ISRCTN23323895 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23323895 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/10/2013
- Registration date
- 08/11/2013
- Last edited
- 12/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Significant bleeding may occur following endobronchial forceps biopsy (a medical procedure that
involves taking a small sample of tissue so that it can be examined under a microscope) or brushing
of tumors in the airways. In some cases, methods such as endobronchial instillation of iced saline
lavage (washing of the organ with saline) and epinephrine may fail to control the bleeding. The
present study aimed to evaluate the effectiveness and safety of a new bronchoscopic technique
using intratumoral injection of tranexamic acid (IIT) for controlling bleeding during forceps biopsy in
patients with endobronchial tumors with a high risk of bleeding.
Who can participate?
Adult male and female patients suspected of lung cancer by signs, symptoms and other diagnostic
tests are eligible to enter the study.
What does the study involve?
Bronchoscopic IIT was performed in those patients who had endoscopically visible tumoral lesions
with continued endobronchial active bleeding following the first attempt of bronchoscopic sampling
by endobronchial forceps biopsy (EBB) or endobronchial needle aspiration (EBNA). Tranexamic acid
(TEA) is injected through a needle into the lesion. After 2-3 minutes of waiting, multiple forceps
biopsy specimens are obtained from the lesion.
What are the possible benefits and risks of participating?
Following IIT, multiple forceps biopsies can be performed without significant bleeding. This makes
procedure more comfortable and safe for patients and saves time for bronchoscopists.
TEA reduces blood loss during operations in a variety of clinical settings, including cardiac surgery,
major orthopedic surgery and gynecological conditions, and decreases death rates in trauma
patients with significant bleeding. Adverse events associated with TEA are uncommon; nausea,
diarrhea and occasionally low blood pressure have been reported with oral or rapid intravenous
administration, respectively.
Where is the study run from?
The Department of Pulmonary Medicine, Meram Medical Faculty, N.E. University, Konya, Turkey.
When is the study starting and how long is it expected to run for?
The study started in October 2009 and is expected to be completed in three years.
Who is funding the study?
Meram Medical Faculty, N.E. University, Konya (Turkey).
Who is the main contact?
Dr Adil Zamani
adzamani@hotmail.com
Contact information
Scientific
Department of Pulmonary Medicine
Meram Medical Faculty
N.E.University
Akyokus Mevkii, Meram
Konya
42080
Türkiye
| adzamani@hotmail.com |
Study information
| Study design | Single-centre off-label use non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Bronchoscopic intratumoral injection of tranexamic acid for prevention of excessive bleeding during multiple forceps biopsy procedure in patients with endobronchial tumors with a high risk of bleeding |
| Study acronym | BITA |
| Study hypothesis | It is hypothesised that a bronchoscopic technique using intratumoral injection of tranexamic acid (IIT) controls bleeding during the multiple forceps biopsy procedure in patients with endobronchial tumors with a high risk of bleeding. |
| Ethics approval(s) | Meram Medical Faculty Ethical Committee, 26/06/2009, Approval number 2009/327 |
| Condition | Lung cancer |
| Intervention | Transamine ampoule (tranexamic acid) is injected through a 22-gauge Wang cytology needle into the lesion in fractional amounts at various points in nominal doses from 250 to 500 mg. All patients are followed up for a week after bronchoscopic procedures. Rarely some lung cancer patients with drug-eluting coronary stents are on continuous dual antiplatelet therapy (aspirin and clopidogrel), and upon consultation and recommendation from the cardiology department, these drugs are not discontinued perioperatively. Therefore,only in this category of patients, due to the high risk of bleeding, the first bronchoscopic sampling is performed by EBNA, and after intratumoral injection of tranexamic acid, multiple EBB specimens are obtained from the lesion. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tranexamic acid |
| Primary outcome measure | Performance of multiple forceps biopsy procedure in patients with endobronchial tumors without producing active bleeding |
| Secondary outcome measures | 1. Adverse effects during and after IIT 2. Cost-effectiveness of the IIT |
| Overall study start date | 13/10/2009 |
| Overall study end date | 18/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Participant inclusion criteria | 1. Written informed consent 2. Adults aged over 18 years, either sex 3. Patients suspected of lung cancer by signs, symptoms, chest radiograph and computed tomography and/or fluorodeoxyglucose positron emission tomography findings |
| Participant exclusion criteria | 1. Unfit to undergo a bronchoscopy 2. History or risk of thrombosis, active thromboembolic disease, subarachnoid hemorrhage 3. A known or suspected bleeding disorder 4. Thrombocytopenia 5. Uremia 6. Disturbances of color vision |
| Recruitment start date | 13/10/2009 |
| Recruitment end date | 18/07/2012 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
42080
Türkiye
Sponsor information
University/education
Meram Medical Faculty
Akyokus Mevkii
Meram
Konya
42080
Türkiye
| iletisim@meramtip.com.tr | |
"ROR" |
https://ror.org/013s3zh21 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2014 | Yes | No |
