A Phase 4 interventional study of Unfractionated heparin and Standard supportive care in Acute Pancreatitis (AP), sponsored by Allied Hospital Faisalabad. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Allied Hospital Faisalabad · Phase 4, Interventional, and Treatment
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:
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.
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:
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.
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.
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.
Therapeutic Interventions:
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.
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Allied Hospital Faisalabad is the lead sponsor of 11 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
* 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 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.
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.
Plan to share: No — 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.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Heparin
Allied Hospital Faisalabad