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

Primary Purpose

Acute Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continuous regional arterial infusion of low molecular weight heparin in celiac trunk
General treatment
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring severe acute pancreatitis;, continuous regional arterial infusion;, low molecular weight heparin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CRAI

Conservative treatment

Arm Description

CRAI of LMWH in the celiac trunk

Conservative treatment without CRAI, control group

Outcomes

Primary Outcome Measures

coagulation related complications
bleeding for the most coagulative parameters
Pancreatic infection

Secondary Outcome Measures

pancreatic necrosis
ICU duration
Hospital duration
Mortality

Full Information

First Posted
June 16, 2012
Last Updated
December 6, 2013
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01626911
Brief Title
Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis
Acronym
CRAI-H
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
severe acute pancreatitis;, continuous regional arterial infusion;, low molecular weight heparin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRAI
Arm Type
Experimental
Arm Description
CRAI of LMWH in the celiac trunk
Arm Title
Conservative treatment
Arm Type
Other
Arm Description
Conservative treatment without CRAI, control group
Intervention Type
Procedure
Intervention Name(s)
Continuous regional arterial infusion of low molecular weight heparin in celiac trunk
Intervention Description
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
Other
Intervention Name(s)
General treatment
Intervention Description
Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.
Primary Outcome Measure Information:
Title
coagulation related complications
Description
bleeding for the most coagulative parameters
Time Frame
14 days after the placement of celiac trunk catheter
Title
Pancreatic infection
Time Frame
28 days
Secondary Outcome Measure Information:
Title
pancreatic necrosis
Time Frame
28 days
Title
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.
Title
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.
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiqin Li, Dr
Phone
+86-025-80860066
Email
kkb9832@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihui Tong, Dr
Phone
+86-025-80860066
Email
njzyantol@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiqin Li, Dr
Organizational Affiliation
Jinling Hospital, School of Medicine, Nanjing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiqin Li, Dr
Phone
+86-025-80860066
Email
kkb9832@gmail.com
First Name & Middle Initial & Last Name & Degree
Lu Ke, Dr
First Name & Middle Initial & Last Name & Degree
Luyao Zhang, Dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
20104197
Citation
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.
Results Reference
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Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis

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