Heparin to Prevent Organ Failure in Acute Pancreatitis (NCT07609771) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Heparin to Prevent Organ Failure in Acute Pancreatitis
Pakistan100 participantsStarted 2026-06
Plain-language summary
This clinical trial is designed to evaluate whether adding a standard blood-thinning medication, Unfractionated Heparin, to standard hospital care can help prevent severe organ failure in patients admitted with acute pancreatitis.
Acute pancreatitis is a sudden and severe inflammation of the pancreas. During this condition, intense inflammation can trigger a hypercoagulable state (excessive blood clotting) in the small blood vessels supplying vital organs. This microvascular clotting can block normal blood flow, starving tissues of oxygen and potentially leading to dangerous, life-threatening multi-organ failure involving the lungs, kidneys, or heart. Currently, standard medical care for acute pancreatitis is purely supportive-consisting of intensive intravenous fluid hydration, pain management, and nutritional support-without any specific targeted drug therapy to halt the disease's progression.
In this study, participating patients are randomly assigned into one of two balanced groups using a randomized lottery method upon their admission to the surgical unit:
1. The Control Group: Receives standard supportive hospital medical care only.
2. The Intervention Group: Receives the same standard supportive medical care plus a continuous, carefully monitored intravenous infusion of Unfractionated Heparin.
The primary objective of the study is to determine if early initiation of this standard anticoagulant therapy preserves blood flow, dampens the severe inflammatory cascade, and successfully prevents the development of new or worsening organ failure. The study will also evaluate secondary clinical endpoints, including the total duration of the patient's hospital stay and the general safety profile of the intervention by monitoring for any adverse bleeding complications.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years or older.
* Confirmed clinical diagnosis of acute pancreatitis based on meeting at least two of the following three revised Atlanta criteria: (1) acute onset of severe, persistent upper abdominal pain; (2) serum amylase or lipase levels elevated to at least three times the upper limit of normal; (3) characteristic findings of acute pancreatitis on cross-sectional abdominal imaging.
* Presentation to the hospital and initiation of the trial protocol within 24 hours of the onset of symptoms.
* Absence of systemic organ failure at the baseline assessment during initial hospital admission.
Exclusion Criteria:
* Baseline organ failure already present at the time of initial hospital admission (defined as a Modified Marshall Score of 2 or more in any organ system).
* Patients with a known history of chronic pancreatitis or recurrent episodes of pancreatitis.
* History of hypersensitivity, allergy, or known adverse reactions to heparin, low molecular weight heparins, or related anticoagulants.
* Active clinically significant bleeding, recent major hemorrhage, known bleeding diathesis, or severe thrombocytopenia (platelet count less than 100,000/mcL).
* Existing indication for therapeutic systemic anticoagulation (such as active deep vein thrombosis, pulmonary embolism, mechanical heart valves, or atrial fibrillation).
* Pregnant or lactating females.
* Refusal to provide informed consent to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of New-Onset Organ Failure
Timeframe: Daily from Day 1 (after baseline assessment at hospital admission) up to Day 7 of hospitalization or until official hospital discharge, whichever occurs first.