Human intestinal ischemia and reperfusio

Phase 2

Recruiting

• Conditions: Intestinal ischemia; oxigen deficiency of the bowel; 10018031; 10047066

• Registration Number: NL-OMON43970
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 69

Inclusion Criteria

Adult patients (18 years of age and older) undergoing major upper abdominal surgery
o Whipple-procedure or pylorus preserving pancreatico duodenectomy (PPPD)
o Ileo-Jejunal bypass surgery
o Roux-en-Y gastric bypass
o Total gastrectomy
o Hepatico jejunostomy
o Pancreaticojejunostomy (Frey*s procedure)
*
Patients who have given an informed consent

Exclusion Criteria

<18 years of age or older but no proper understanding of the research proposal
Inflammatory bowel disease
Celiac disease
Acute major abdominal procedures
Patients who have refused informed consent;For the population who will receive tranexamic acid additional exclusion criteria have been formulated: ;Active or history of thrombo-embolic disorders such as deep venous thrombosis, pulmonary embolism or cerebral embolism
History of blood coagulation disorder (hypercoagulation state)
Subarachnoid hemorrhage
Disseminated intravascular coagulation (DIS)
Severe renal insufficiency: i.e. serum kreatinine >150 µmol/L
History of convulsions
Pregnancy
Known hypersensitivity of allergy for tranexamic acid
Simultaneous use of thrombolytics (e.g. alteplase, streptokinase)
Simultaneous use of hormonal anticonceptives or other substances that induce hemostasis. ;For the population who will receive doxycycline additional exclusion criteria have been formulated: ;Known hypersensitivity of allergy for tetracyclines.
Severe liver function disorder i.e. ASAT or ALAT or AF or γ-GT >150 U/L whether or not combined with severe renal insufficiency: i.e. serum kreatinine >150 µmol/L.
Severe renal insufficiency: i.e. serum kreatinine >150 µmol/L.
Porphyria
Myasthenia gravis
Simultaneous usage (or just before or after administration of doxycycline) of oral retinoids or substances containing metalions (such as antagel or ironpreparations)
Simultaneous use of methoxyflurane (anesthetic) or oral contraceptives
Bodyweight beneath 50 kg
History of blood coagulation disorder (inert hypocoagulation state)
Pregnancy or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint in this study is inflammation (neutrophil influx,<br /><br>complement activation, interleukins, TNF-a, COX 1-2) and protease activity in<br /><br>tissue as well as in blood plasma. An important element of our study is the<br /><br>alteration in these variables after administration of a protease-inhibitor<br /><br>and/or MMP-inhibitor compared to a placebo.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameter is intestinal cell damage, which will be<br /><br>evaluated by assessment of plasma levels of I-FABP, ILBP as well as tissue<br /><br>stainings for morphology, tight junctions, apoptosis, goblet cells, mucines,<br /><br>cell proliferation, I-FABP, L-FABP and SM22. An important element of our study<br /><br>is the alteration in these variables after administration of a<br /><br>protease-inhibitor and/or MMP-inhibitor compared to a placebo.</p><br>