Health TrialsbyHealthPanel

Tranexamic Acid During Colonic Endoscopic Resection Procedures

ConditionColon Neoplasm
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssaf-Harofeh Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Age > 18 years

Disqualifiers

patients with histories of allergic reactions to TXA

history of seizures

pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic acid

    Drug

    Submucosal injection of standard solution including TXA during EMR procedure

  • Standard

    Drug

    Injection of standard solution

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Tranexamic Acid groupExperimental treatment 1 intervention
Group B: Standard therapy groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postprocedural bleeding

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

Time frame
Within 2 weeks of procedure

Secondary outcomes

1

Intraprocedural bleeding

Bleeding during the procedure requiring treatment

Time frame
During the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assaf-Harofeh Medical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now