Unfractionated Heparin for Organ Failure Prevention in Acute Pancreatitis: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
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 Control Group: Receives standard supportive hospital medical care only.
- 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.
详细描述
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. 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard supportive care (Other)
研究者
Muhammad Asad Parvez
Postgraduate resident
Allied Hospital Faisalabad