Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis

Study Overview
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Brief Summary
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Our animal studies found that continuous regional arterial infusion (CRAI in the celiac trunk) of low molecular weight heparin (LMWH) could alleviate inflammation, improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished). In this study, the investigators aim to evaluate the effects of CRAI of LMWH in the treatment of SAP patients. The investigators suppose CRAI could help improve the outcomes of these patients.

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Procedure: Continuous regional arterial infusion of low molecular weight heparin in celiac trunk
* Other: General treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms and signs of severe acute pancreatitis according to Atlanta criteria Within 3 days from the onset of the disease Available for interventional treatment(not sensible to radiocontrast agent) Exclusion Criteria: Pregnant pancreatitis Receiving surgery or aspiration before;need of early surgery Patients with coagulation disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRAI<br>CRAI of LMWH in the celiac trunk | Procedure: Continuous regional arterial infusion of low molecular weight heparin in celiac trunk<br>* Put a catheter to the celiac trunk through interventional technique. The approach to celiac trunk was via a femoral artery approach.The tip of the arterial catheter (4F) was placed in celiac trunk which could perfuse the pancreas.After that, continuous infusion of low molecular weight heparin through the catheter will be applied during the first 5 days after placement.<br>Other: General treatment<br>* Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.<br>|
| Other: Conservative treatment<br>Conservative treatment without CRAI, control group | Other: General treatment<br>* Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coagulation related complications | bleeding for the most coagulative parameters | 14 days after the placement of celiac trunk catheter | 
| Pancreatic infection |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic necrosis |  | 28 days | 
| ICU duration |  | Participants will be followed until the date of discharge from the ICU,assessed up to 6 weeks. Patients who die during hospitalization are excluded from this measurement. | 
| Hospital duration |  | Participants will be followed until the date of discharge from the hospital,assessed up to 3 months. Patients who die during hospitalization are excluded from this measurement. | 
| Mortality |  | Participants will be followed until the date of discharge or the date of death from any cause, whichever came first, assessed up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe acute pancreatitis;, continuous regional arterial infusion;, low molecular weight heparin