Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
1. Scheduled to undergo an elective (non-emergent) bowel resection with a planned stoma
via laparotomy or minimally invasive technique. This includes any subject in which a
resection of the small intestine, colon, or rectum is performed for any elected
indication.
2. Planned stoma takedown or other planned abdominal surgery within 8 months of the
initial surgery.
3. Willing to perform and comply with all study procedures including attending clinic
visit as scheduled and completion of a second surgery for stoma takedown or other
abdominal surgery and to determine the presence of intra-abdominal adhesions.
4. Has been informed of the nature of the study (either the subject or their legal
representative), agrees to its provisions, and has provided written informed consent.
Exclusion Criteria:
1. < 18 or > 80 years of age.
2. Requires emergency bowel surgery.
3. Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel
disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's
Disease, or ulcerative colitis.
Note: This does not apply to previous surgery such as hernia repair unrelated to IBD.
4. American Society of Anesthesiologists (ASA) Class 4 or 5.
5. Insulin dependent diabetes mellitus.
6. Known inability to take the study drug orally (i.e., complete small bowel obstruction).
7. Has contraindications or potential risk factors to taking TXA. These include subjects
with:
1. Known sensitivity to TXA;
2. Recent craniotomy (past 30 days);
3. Active cerebrovascular bleed;
4. Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism,
cerebral thrombosis, ischemic stroke, or acute coronary syndrome);
5. Acute promyelocytic leukemia taking all-trans retinoic acid for remission
induction; or
6. Continuing use of a combined hormonal contraceptive and or combined hormonal
replacement therapy (including combined hormonal pill, patch, or vaginal ring).
8. Has the following risk factors for thromboembolic disease:
1. Known medical history of congenital or acquired thrombophilia such as, but not
limited to patients with:
- Sickle cell disease;
- Nephrotic syndrome;
- Factor V Leiden;
- Prothrombin gene mutation;
- Protein C or S deficiency;
- Antithrombin III deficiency;
- Antiphospholipid syndrome.
2. Stage IV malignant neoplasm;
3. Neurologic paresis, partial paralysis, or paralysis;
4. Pacemaker;
5. History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or
rental venous/arterial occlusion;
9. History of or current seizure disorder.
10. Patients with myeloproliferative disorders.
11. Body Mass Index (BMI) > 40.
12. Any other condition that, in the opinion of the Investigator, would preclude the
subject from being an appropriate candidate for the study, including severe renal or
hepatic impairment.
13. Planned treatment with alvimopan (Entereg®) during study participation period.
14. Planned use of 4% icodextrin (Adept®) or SEPRAFILM during the first surgery.
15. Received any other investigational therapy within 4 weeks prior to Randomization
16. Chronic opioid usage, defined by the American Pain Society as daily or near-daily use
of opioids for at least 90 days.
17. Female subjects of childbearing potential with a positive urine or serum pregnancy
test or who are not taking (or not willing to take) acceptable birth control measures
(abstinence, intrauterine devices, contraceptive implants or barrier methods) through
Day 30. Additionally, those women who are lactating and insist on breast feeding
within 5 days of the last dose of study drug.
18. Known history of radiation enteritis.
Eligibility last updated 7/19/22. Questions regarding updates should be directed to the study team contact.