Heparin to Prevent Organ Failure in Acute Pancreatitis

NCT07609771 | Not Yet Recruiting Phase 4

• 1 other identifier: 48.ERC/FMU/2024-25/208
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.The Control Group: Receives standard supportive hospital medical care only.
2. 2.The Intervention Group: Receives the same standard supportive medical care plus a continuous, carefully monitored intravenous infusion of Unfractionated Heparin.

Conditions

Acute Pancreatitis (AP)

Outcome Measures

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.

  Daily from Day 1 (after baseline assessment at hospital admission) up to Day 7 of hospitalization or until official hospital discharge, whichever occurs first.

Study Arms (2)

Experimental: Heparin Group

EXPERIMENTAL

Patients in this arm will receive an adjunctive anticoagulant protocol consisting of Unfractionated Heparin (UFH) administered via a continuous intravenous infusion pump. The UFH therapy will be initiated within the first 24 hours of hospital admission. In addition to this active pharmacological intervention, all patients in this group will concurrently receive standard institutional supportive medical care for acute pancreatitis, which includes aggressive intravenous fluid resuscitation, standardized analgesia for pain management, close hemodynamic monitoring, and early nutritional support.

Drug: Unfractionated heparin

Standard Care Group

ACTIVE COMPARATOR

Patients in this arm will receive standard institutional supportive medical therapy for acute pancreatitis as per ward protocols. This standard care regimen consists of aggressive, tailored intravenous fluid resuscitation (primarily balanced crystalloids such as Ringer's Lactate) titrated closely to clinical endpoints, standardized analgesia for pain management, regular vital signs and urine output monitoring, and early targeted nutritional support. Patients in this group will not receive any active adjunctive anticoagulant therapy or continuous heparin infusions during their study participation.

Other: Standard supportive care

Interventions

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.

Experimental: Heparin Group

Standard supportive care OTHER

Standard 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.

Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allied Hospital Faisalabad: lead

Study Sites (1)

Allied Hospital, Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (1)

• Tozlu M, Kayar Y, Ince AT, Baysal B, Senturk H. Low molecular weight heparin treatment of acute moderate and severe pancreatitis: A randomized, controlled,open-label study. Turk J Gastroenterol. 2019 Jan;30(1):81-87. doi: 10.5152/tjg.2018.18583.

  PMID: 30289392 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Heparin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Muhammad Asad Parvez, MBBS

CONTACT

+923217626547; asadparvez2@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)