Tranexamic Acid During Upper GI Endoscopic Resection Procedures

August 6, 2023 updated by: Assaf-Harofeh Medical Center

Comparison Between Epinephrine Versus Tranexamic Acid Usage During Upper Gastrointestinal Tract Endoscopic Resection Procedures for the Reduction of Intraprocedural and Postprocedural Bleeding

Endoscopic resection of gastrointestinal lesions may prevent cancer. However, resection 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 upper gastrointestinal lesions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 and post-ER bleeding 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.

Intraprocedural bleeding in the stomach and duodenum is more frequent and may be as high as 11.5% and 19.3%, respectively. Delayed bleeding has been reported at about 5% for these sites.

Management of bleeding 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; hemoclip placement or proton-pump inhibitor treatment, 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, epinephrine has a short time-of-action and for long procedures it requires multiple doses to be injected. This can result in systemic effects such as severe hypertension, ventricular tachycardia, and intestinal ischemia, and may also 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.

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.

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.

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 most frequently described contraindications to TXA administration include patients with histories of allergic reactions to TXA, seizures, and patients with acute renal failure or chronic kidney disease.

The investigators propose that the use of TXA in the injection gel during ER procedures will be as effective as epinephrine usage in reducing intraprocedural and postprocedural bleeding, while also decreasing the incidence of side effects including abdominal pain.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Be'er Ya'aqov, Israel, 70300
        • Recruiting
        • Shamir Medical Center
        • Contact:
          • Anton Bermont, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic acid
During the ER procedure, de-identified injectate solution will be introduced. Study group: 9 ml of standart solution for injection [Consisit of: 6 ml indigo carmine + 500 ml succinylated gelatin 4% (Gelofusine; B. Braun, Crissier, Switzerland)] + 1 ml (100mg) of TXA (tranexamic acid).
Drug: Tranexamic acid
Tranexamic acid will be injected as part of the injectate during endoscopic resection.
Other Names:
  • Hexakapron
Active Comparator: Epinephrine
During the ER procedure, de-identified injectate solution will be introduced. 9 ml of standart solution for injection [Consisit of: 6 ml indigo carmine + 500 ml succinylated gelatin 4% (Gelofusine; B. Braun, Crissier, Switzerland)] + 1 ml epinephrine 1:100,000 + 1 ml saline 0.9%.
Drug: Epinephrine injection
Epinephrine will be injected as part of the standard injectate used during endoscopic resection.
Other Names:
  • Adrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraprocedural bleeding
Time Frame: During procedure
To compare the severity of intraprocedural bleeding between those receiving TXA and those receiving epinephrine.
During procedure
Postprocedural bleeding
Time Frame: 2 weeks post-procedure
To compare the severity of postprocedural bleeding between those receiving TXA and those receiving epinephrine.
2 weeks post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 2 weeks post-procedure
To compare the number and severity of occurrences of abdominal pain, tachycardia, and hypertension between those receiving TXA and those r receiving epinephrine.
2 weeks post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Anton Bermont, MD, Shamir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 8, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0118-22-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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