Condition category
Cancer
Date applied
26/10/2013
Date assigned
08/11/2013
Last edited
12/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adil Zamani

ORCID ID

Contact details

Department of Pulmonary Medicine
Meram Medical Faculty
N.E.University
Akyokus Mevkii
Meram
Konya
42080
Turkey
-
adzamani@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

Meram Medical Faculty Ethical Committee, 26/06/2009, Approval number 2009/327

Study design

Single-centre off-label use non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Tranexamic acid

Primary outcome measures

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 trial start date

13/10/2009

Overall trial end date

18/07/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

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

Turkey

Trial participating centre

Department of Pulmonary Medicine
Konya
42080
Turkey

Sponsor information

Organisation

Necmettin Erbakan (NE) University (Turkey)

Sponsor details

Meram Medical Faculty
Akyokus Mevkii
Meram
Konya
42080
Turkey
-
iletisim@meramtip.com.tr

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Meram Medical Faculty, N.E. University, Konya (Turkey)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24581173

Publication citations

Additional files

Editorial Notes