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AzTrials

Colon NeoplasmPhase 4NCT05345613

Tranexamic Acid During Colonic Endoscopic Resection Procedures

A Phase 4 study testing Tranexamic acid and Standard in people with Colon Neoplasm, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Colonoscopy with polypectomy reduces the incidence and mortality associated with colon cancer. However, polypectomy is associated with adverse events such as bleeding. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects and may prevent bleeding. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Neoplasm
What is being tested?
Tranexamic acid and Standard
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 siteIsrael
Study dates
1 May 2022to 1 Oct 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients referred for endoscopic resection of non-neoplastic and neoplastic lesions in the colon presenting to our tertiary academic center.
  • Age > 18 years

Who cannot join

  • patients with histories of allergic reactions to TXA
  • history of seizures
  • pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anton Bermont, MD contact

+972526944145

bermont@doctor.com

Sergei Vosko, MD contact

sergeivosko@gmail.com

Israel1 site, 1 recruiting
  • Shamir Medical Center

    Be’er Ya‘aqov, 70300

    Anton Bermont, MD

    Recruiting

Other trials in Israel

About this study

Official title: Usage of Tranexamic Acid During Colonic Endoscopic Resection Procedures for Reduction Intraprocedural and Postprocedural Bleeding

Colonoscopy with polypectomy reduces the incidence and mortality associated with colon cancer. However, polypectomy is associated with adverse events such as bleeding. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects and may prevent bleeding. The investigators aim to evaluate the effect of local TXA on preventing intraprocedural and postprocedural bleeding in patients undergoing endoscopic mucosal resection (EMR) of large colon polyps.

Read the detailed description

Endoscopic resection (ER) is an endoscopic technique used for the removal of sessile or flat neoplasms confined to the superficial layers (mucosa and submucosa) of the gastrointestinal (GI) tract.

This technique is not without risk, and clinically significant intraprocedural bleeding (CSIPB) and post-ER bleeding (CSPEB) remain the most frequently encountered serious adverse event.

The bleeding rate associated with ER varies for the different regions of the GI tract. This is most probably due to differences in the vascularity within the wall of the GI tract in each region.

For colonic ER, intraprocedural bleeding occurs in about 11% of cases with delayed bleeding up to 11%.

Management of CSIPB and CSPEB is often resource intensive and may necessitate hospitalization, blood transfusion, and repeat intervention. Some techniques, such as soft coagulation with the tip of a snare, epinephrine injection or hemoclip placement are used to decrease the risk of bleeding or treat active bleeding.

Diluted epinephrine, which causes vasoconstriction, is often added to the submucosal injection fluid because of the theoretical benefit of decreasing bleeding.

However, submucosal injection of epinephrine potentially can result in systemic effects such as severe hypertension, ventricular tachycardia, and intestinal ischemia.

Moreover, epinephrine injection may increase postprocedural pain and prolong patient observation after the procedure.

Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects by inhibition of lysine binding sites on plasminogen molecules and therefore stabilizes the fibrin meshwork produced by secondary hemostasis. TXA was patented by Dr. S. Okamoto in 1957, and it was found to be significantly more potent than a precursor molecule known as epsilon-amino-caproic acid.

During the past few years, TXA has been 'rediscovered' and is currently used in many conditions that are associated with either overt or occult hemorrhage. It is one of the most frequently cited drugs in recent surgical publications involving nearly all surgical specialties.

After the CRASH-2 study which showed that administration of TXA to bleeding trauma patients within 3 hours of injury significantly reduced the risk of death due to bleeding and all-cause mortality without increasing the risk of vascular occlusive events, it has become an important part of trauma management.

It is also widely used in gynecological practice. Early treatment with TXA reduces death due to bleeding in women with post-partum hemorrhage, as well as total blood loss and transfusion requirements in hemorrhage after caesarean delivery. Therefore, TXA has been recommended by the WHO as part of postpartum hemorrhage management.

In gynecologic surgeries such as hysterectomy or myomectomy, the use of TXA significantly reduces blood loss without evidence of thrombotic events or deaths.

TXA is also commonly used in orthopedic surgery, either systemically or topically, to reduce excessive bleeding and transfusion requirements.

Other hemorrhagic conditions in which TXA has been shown effective are epistaxis, hemoptysis, endoscopic ear surgery, mastectomy, and hereditary hemorrhagic telangiectasia with bleeding.

For gastrointestinal bleeding, the effectiveness of TXA is controversial. Based on the most recent large randomized controlled trial, TXA is unlikely to confer additional benefit beyond the current standard of care in patients with severe upper or lower GI bleeding. However, this study had some limitations as most patients presented more than three hours after bleeding onset and a large portion were treated for presumed variceal bleeds.

According to some other studies, TXA use may be effective in reducing severe bleeding, blood transfusions, length of stay, and hospitalization costs, need for urgent endoscopy, the risk of re-bleeding, and the need for surgery. A recent meta-analysis revealed that TXA significantly reduced the rates of continued bleeding, urgent endoscopic intervention, and mortality compared to placebo.

Topical use of TXA may be more beneficial than systemic use as it may provide a higher drug concentration on the wound surface with negligible systemic concentrations. Most publications concerning topically administered TXA come from orthopedic literature where instilling TXA as a bolus into the joint reduces bleeding. Recently, a study revealed that intradermal injections of TXA in dermatological surgery reduces bleeding, especially in those on anticoagulant medications.

In gastroenterology practice, the topical use of TXA was investigated in one recent study which revealed that it conferred no additional benefit over standard care in patients with upper gastrointestinal hemorrhage.

In orthopedic patients, in addition to a reduction in bleeding, TXA was found to significantly improve postoperative pain.

While TXA is an inhibitor of fibrinolysis, and therefore might theoretically increase the risk of thrombotic vascular events, most studies show no increased risk of thromboembolism. This finding has been consistent with all routes of TXA administration including IV, topical/intra-articular, and other routes.

The investigators propose that the addition of TXA instead of adrenaline into the gel for injection during ER procedures may reduce intraprocedural and postprocedural bleeding, while also decreasing side effects of adrenaline injection including postprocedural pain.

Conditions
Colon Neoplasm
Being tested
Tranexamic acid, Standard
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    Also called TXA, Cyklokapron

    Submucosal injection of standard solution including TXA during EMR procedure

  • StandardDrug

    Also called adrenaline, epinephrine

    Injection of standard solution

Study groups in NCT05345613
Study groupRoleWhat they receive
Tranexamic Acid groupExperimentalstandard solution for injection with TXA and without adrenaline
Receives: Drug: Tranexamic acid
Standard therapy groupPlacebo comparatorstandard solution for injection including adrenaline
Receives: Drug: Standard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postprocedural bleeding

    Overt postprocedural bleeding, whether including a drop in hemoglobin or not

    Measured: Within 2 weeks of procedure

Secondary outcomes (1)
  1. Intraprocedural bleeding

    Bleeding during the procedure requiring treatment

    Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2022
  2. Study start1 May 2022
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05345613
Sponsor's protocol ID
0017-22-ASF
Status last verified
Jan 2026
First submitted
10 Apr 2022
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.

    PubMed 26077453
  • Park CH, Lee SK. Preventing and controlling bleeding in gastric endoscopic submucosal dissection. Clin Endosc. 2013 Sep;46(5):456-62. doi: 10.5946/ce.2013.46.5.456. Epub 2013 Sep 30.

    PubMed 24143302
  • Fahrtash-Bahin F, Holt BA, Jayasekeran V, Williams SJ, Sonson R, Bourke MJ. Snare tip soft coagulation achieves effective and safe endoscopic hemostasis during wide-field endoscopic resection of large colonic lesions (with videos). Gastrointest Endosc. 2013 Jul;78(1):158-163.e1. doi: 10.1016/j.gie.2013.02.030. Epub 2013 Apr 6.

    PubMed 23570622
  • Lee HS, Jeon SW, Kwon YH, Nam SY, Shin S, Kim R, Ahn S. Prophylactic endoscopic coagulation to prevent delayed post-EMR bleeding in the colorectum: a prospective randomized controlled trial (with videos). Gastrointest Endosc. 2019 Nov;90(5):813-822. doi: 10.1016/j.gie.2019.05.039. Epub 2019 Jun 5.

    PubMed 31175874
  • Liaquat H, Rohn E, Rex DK. Prophylactic clip closure reduced the risk of delayed postpolypectomy hemorrhage: experience in 277 clipped large sessile or flat colorectal lesions and 247 control lesions. Gastrointest Endosc. 2013 Mar;77(3):401-7. doi: 10.1016/j.gie.2012.10.024. Epub 2013 Jan 11.

    PubMed 23317580
  • Castro R, Libanio D, Pita I, Dinis-Ribeiro M. Solutions for submucosal injection: What to choose and how to do it. World J Gastroenterol. 2019 Feb 21;25(7):777-788. doi: 10.3748/wjg.v25.i7.777.

    PubMed 30809079
  • Rex DK, Lahr RE, Peterson MM, Vemulapalli KC. Impact of including epinephrine in the submucosal injectate for colorectal EMR on postprocedural pain: a randomized controlled trial. Gastrointest Endosc. 2022 Mar;95(3):535-539.e1. doi: 10.1016/j.gie.2021.11.043. Epub 2021 Dec 9.

    PubMed 34896443
  • Cai J, Ribkoff J, Olson S, Raghunathan V, Al-Samkari H, DeLoughery TG, Shatzel JJ. The many roles of tranexamic acid: An overview of the clinical indications for TXA in medical and surgical patients. Eur J Haematol. 2020 Feb;104(2):79-87. doi: 10.1111/ejh.13348. Epub 2019 Dec 16.

    PubMed 31729076
  • Watts G. Utako Okamoto. Lancet. 2016 Jun 4;387(10035):2286. doi: 10.1016/s0140-6736(16)30697-3. No abstract available.

    PubMed 27308678

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic acid and Standard in people with Colon Neoplasm, run by Assaf-Harofeh Medical Center 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anton Bermont, MD (+972526944145, bermont@doctor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprocedural bleeding (time frame: Within 2 weeks of procedure). 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 NCT05345613, which also lists 9 linked publications.

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 13 Jan 2026.

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