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

NCT ID: NCT01626911

Last Updated: 2013-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).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

Detailed Description

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Conditions

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Acute Pancreatitis

Keywords

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severe acute pancreatitis; continuous regional arterial infusion; low molecular weight heparin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRAI

CRAI of LMWH in the celiac trunk

Group Type EXPERIMENTAL

Continuous regional arterial infusion of low molecular weight heparin in celiac trunk

Intervention Type PROCEDURE

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.

General treatment

Intervention Type OTHER

Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.

Conservative treatment

Conservative treatment without CRAI, control group

Group Type OTHER

General treatment

Intervention Type OTHER

Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.

Interventions

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Continuous regional arterial infusion of low molecular weight heparin in celiac trunk

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.

Intervention Type PROCEDURE

General treatment

Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Weiqin Li

Director of surgical ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weiqin Li, Dr

Role: PRINCIPAL_INVESTIGATOR

Jinling Hospital, School of Medicine, Nanjing University

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weiqin Li, Dr

Role: CONTACT

Phone: +86-025-80860066

Email: [email protected]

Zhihui Tong, Dr

Role: CONTACT

Phone: +86-025-80860066

Email: [email protected]

Facility Contacts

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Weiqin Li, Dr

Role: primary

References

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Lu XS, Qiu F, Li YX, Li JQ, Fan QQ, Zhou RG. Effect of lower-molecular weight heparin in the prevention of pancreatic encephalopathy in the patient with severe acute pancreatitis. Pancreas. 2010 May;39(4):516-9. doi: 10.1097/MPA.0b013e3181c3c954.

Reference Type BACKGROUND
PMID: 20104197 (View on PubMed)

Other Identifiers

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CRAI-H

Identifier Type: -

Identifier Source: org_study_id