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
Qualifiers
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
Treatments tested in this trial
- Unfractionated heparin
- Standard supportive care
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Allied Hospital, Faisalabad Status unavailable 38000, Faisalābad, Punjab Province
Pakistan
PakistanSponsors and collaborators
Source ClinicalTrials.gov