Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis (CRAI-H)

December 6, 2013 updated by: Weiqin Li, Nanjing University School of Medicine

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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
        • Contact:
        • Sub-Investigator:
          • Lu Ke, Dr
        • Sub-Investigator:
          • Luyao Zhang, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRAI
CRAI of LMWH in the celiac trunk
Procedure: 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.
Other: General treatment
Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.
Other: Conservative treatment
Conservative treatment without CRAI, control group
Other: General treatment
Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coagulation related complications
Time Frame: 14 days after the placement of celiac trunk catheter

bleeding for the most

coagulative parameters
14 days after the placement of celiac trunk catheter
Pancreatic infection
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
pancreatic necrosis
Time Frame: 28 days
28 days
ICU duration
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Investigators

  • Principal Investigator: Weiqin Li, Dr, Jinling Hospital, School of Medicine, Nanjing University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 16, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 6, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAI-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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