Health Condition 1: K85- Acute pancreatitis
Conditions
Interventions
Intervention1: Low Molecular Weight Heparin (Enoxaparin): Patients in the treatment arm will receive therapeutic subcutaneous LMWH (enoxaparin) 40 mg for patients less than 55 kg weight and 60 mg (0.6
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients presenting within 72 hours of onset of abdominal pain. 2. Diagnosis of Acute Pancreatitis as per the revised Atlanta Classification. 3. Presence of SIRS at least 12 hours apart at presentation.
Exclusion criteria
Exclusion criteria: 1. Patients with Chronic Pancreatitis. 2. Pregnancy 3. Major comorbidity such as decompensated cirrhosis, heart failure, significant lung parenchymal or airway disease, uncontrolled diabetes, or end stage chronic kidney disease. 4. Any untreated malignant disease 5. Patient already on anticoagulation therapy 6. Patient having bleeding diathesis 7. History of bleeding in the past 2 weeks 8. Brain dead patient or patients with multi organ failure at admission (at least two organ failure each of grade less than or equal to 2) or any grade 4 organ failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the proportion of patients with moderate or severe acute pancreatitis at day 30 between the low molecular weight heparin and placebo arm.Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events: a. Gastrointestinal bleeding defined as hematemesis or melena leading to a fall in hemoglobin by at least 1g/dL. b. Heparin induced thrombocytopenia: It will be defined as thrombocytopenia less than 150,000/cmm and/or thrombosis and temporal association with the use of intervention after excluding other causes of thrombocytopenia. c. Bleeding into the pancreatic bed defined as intracravitary bleed on a CT-scan or blood through the percutaneous drainage catheter.Timepoint: ;Difference in the cumulative mean organ failure score at day 30 between the groups.Timepoint: 4 weeks;Difference in the presence and extent of Pancreatic or peri-pancreatic necrosis As assessed by the CT severity score in the 2nd week of illness. We will perform CECT abdomen at day 14 in those patients who have undergone CECT abdomen within first 72 hours of onset of pain in 20% or more of the whole cohort.Timepoint: 2 weeks;Incidence of deep vein thrombosis and thrombosis of splenic, portal and mesenteric veinsTimepoint: ;Difference in the development of Infected Pancreatic NecrosisTimepoint: ;Difference in the in-hospital mortalityTimepoint: ;Difference in the duration of hospital stayTimepoint: ;Difference in the incidence of multiorgan failureTimepoint: ;Difference in the need for drainage of peripancreatic collecctions (endoscopic or percutaneous)Timepoint: ;Difference in the need for endoscopic or surgical necrosectomyTimepoint: | — |
Countries
India
Contacts
Public ContactSoumya Jagannath Mahapatra
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed