Heparin to Prevent Organ Failure in Acute Pancreatitis

Unfractionated Heparin for Organ Failure Prevention in Acute Pancreatitis: A Randomized 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Pancreatitis (AP)
• Intervention / Treatment: Drug: Unfractionated heparin; Other: Standard supportive care

Detailed Description

This randomized controlled clinical trial is conducted to evaluate the clinical efficacy and safety of early, continuous intravenous administration of Unfractionated Heparin (UFH) as an adjunctive treatment to mitigate the development and progression of systemic multi-organ failure in patients presenting with acute pancreatitis.

Clinical Workflow and Protocol:

1. Patient Screening and Enrollment:

   Patients presenting to the emergency department or the surgical wards with a clinical diagnosis of acute pancreatitis are assessed immediately for eligibility based on pre-established clinical parameters. Acute pancreatitis is diagnosed using standard clinical criteria, requiring at least two of the following: characteristic severe abdominal pain, serum amylase or lipase levels elevated to at least three times the upper limit of normal, or characteristic cross-sectional abdominal imaging findings.

2. Baseline Assessments:

   Upon securing formal written informed consent, enrolled patients undergo an immediate baseline clinical evaluation. Baseline laboratory parameters-including a complete blood count (CBC), serum electrolytes, renal function tests (serum creatinine and blood urea), liver function tests, serum amylase/lipase, and arterial blood gases (ABGs)-are drawn. Baseline physiological parameters are recorded to calculate initial disease severity and multi-organ function scores.

3. Randomization and Group Allocation:

   Following baseline verification, patients are randomly allocated in a 1:1 ratio to either the Intervention Group (Group A) or the Control Group (Group B) utilizing a randomized lottery method managed through sequentially numbered, opaque, sealed envelopes to ensure allocation concealment.

4. Therapeutic Interventions:

   • Control Group (Group B): Patients receive standard institutional supportive medical therapy for acute pancreatitis. This includes aggressive tailored intravenous fluid resuscitation (primarily balanced crystalloids like Ringer's Lactate) titrated to clinical endpoints, standardized analgesia for pain management, close hemodynamic monitoring, and early targeted nutritional support.
   • Intervention Group (Group A): Patients receive the identical standard institutional supportive medical therapy protocol provided to the control group. In addition, an active anticoagulant protocol is initiated within the first 24 hours of admission, consisting of Unfractionated Heparin administered via a continuous intravenous infusion pump.

5. Safety Monitoring and Titration:

   To maximize patient safety and evaluate potential adverse events, patients receiving the intravenous UFH protocol undergo rigorous monitoring. Coagulation profiles, including Activated Partial Thromboplastin Time (aPTT), are checked regularly to guide safe administration. Patients in both groups are carefully monitored daily by the clinical team for any clinical signs of minor or major bleeding complications, such as hematemesis, melena, epistaxis, or an unexplained drop in hemoglobin levels.

6. Outcome Evaluation:

All participating patients are evaluated daily throughout their acute hospital stay. The development of systemic complications is tracking objectively using the Modified Marshall Scoring System, which grades respiratory, cardiovascular, and renal organ function daily from admission through Day 14 or until official hospital discharge. Total duration of hospital stay and all-cause clinical outcomes are recorded at the time of discharge.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Muhammad Asad Parvez, MBBS; Phone Number: +923217626547; Email: asadparvez2@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Faisalābad, Punjab Province, Pakistan, 38000
      • Allied Hospital, Faisalabad
      • Contact: Muhammad Asad Parvez, MBBS; Phone Number: 00923217626547; Email: asadparvez2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Heparin Group; 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; 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.
Active Comparator: Standard Care Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Allied Hospital Faisalabad

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Carbohydrates; Glycosaminoglycans; Polysaccharides; Heparin
• Other Study ID Numbers: 48.ERC/FMU/2024-25/208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly to maintain absolute patient confidentiality and protect sensitive clinical information in accordance with local institutional ethical board guidelines. The aggregated statistical results, final data tables, and study conclusions will be fully disseminated through peer-reviewed publication and academic presentation upon completion of the trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No