Heparin to Prevent Organ Failure in Acute Pancreatitis
ConditionAcute Pancreatitis (AP)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAllied Hospital Faisalabad
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Unfractionated heparin
Drug* Route: Continuous intravenous (IV) infusion via a calibrated pump or micro-drip controller to maintain stable serum drug levels. * Timing: Initiated within the first 24 hours of hospital admission, immediately following the clinical diagnosis of acute pancreatitis on the surgical ward. * Dosing: Administered as a continuous weight-adjusted maintenance infusion titrated per institutional safety guidelines for non-cardiac anticoagulation. No loading bolus is given. * Duration: Maintained continuously for up to 7 days, or until clinical resolution of symptoms and transition to oral intake. * Monitoring: Regular tracking of Activated Partial Thromboplastin Time (aPTT) and daily clinical screening for signs of bleeding (e.g., hematemesis, melena, epistaxis). * Discontinuation: Immediate termination if a major bleeding event occurs or urgent surgical/radiological intervention is required.
Standard supportive care
Other interventionStandard institutional supportive medical therapy for acute pancreatitis, including intravenous fluid resuscitation (Ringer's Lactate), standardized analgesia for pain management, close clinical monitoring, and early nutritional support. No anticoagulant infusions will be administered.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Experimental: Heparin GroupExperimental treatment 1 intervention
Group B: Standard Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of New-Onset Organ Failure
This outcome tracks the proportion of patients who develop new-onset systemic organ failure during their hospital stay among individuals who had no baseline organ failure at the time of admission. Organ failure will be objectively assessed using the Modified Marshall Scoring System, evaluating three main organ systems: respiratory (PaO2/FiO2 ratio), renal (serum creatinine), and cardiovascular (systolic blood pressure). A score of 2 or more in any of these systems indicates the development of organ failure.
Time frame
Daily from Day 1 (after baseline assessment at hospital admission) up to Day 7 of hospitalization or until official hospital discharge, whichever occurs first.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Allied Hospital, Faisalabad Status unavailable 38000, Faisalābad, Punjab Province
Pakistan
PakistanSponsors and contacts
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Source ClinicalTrials.gov
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