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

Not Applicable

• Conditions: Acute Pancreatitis
• Interventions: Procedure: Continuous regional arterial infusion of low molecular weight heparin in celiac trunk; Other: General treatment

• Registration Number: NCT01626911
• Lead Sponsor: Nanjing University School of Medicine

Brief Summary

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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-06-16
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-25
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Last Update Submitted: 2013-12-06
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRAI	Continuous regional arterial infusion of low molecular weight heparin in celiac trunk	CRAI of LMWH in the celiac trunk
CRAI	General treatment	CRAI of LMWH in the celiac trunk
Conservative treatment	General treatment	Conservative treatment without CRAI, control group

Primary Outcome Measures

Name	Time	Method
coagulation related complications	14 days after the placement of celiac trunk catheter	bleeding for the most; coagulative parameters
Pancreatic infection	28 days

Secondary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China; 🇨🇳 Nanjing, Jiangsu, China