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Heparin to Prevent Organ Failure in Acute Pancreatitis

31 juillet 2026 mis à jour par: Muhammad Asad Parvez, Allied Hospital Faisalabad

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 38000
        • Allied Hospital, Faisalabad
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Comparateur actif: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of New-Onset Organ Failure
Délai: Daily from Day 1 (after baseline assessment at hospital admission) up to Day 7 of hospitalization or until official hospital discharge, whichever occurs first.
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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Allied Hospital Faisalabad

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 novembre 2026

Achèvement de l'étude (Estimé)

1 novembre 2026

Dates d'inscription aux études

Première soumission

20 mai 2026

Première soumission répondant aux critères de contrôle qualité

20 mai 2026

Première publication (Réel)

27 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 48.ERC/FMU/2024-25/208

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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