NCT01626911

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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

2.3 years

First QC Date

June 16, 2012

Last Update Submit

December 6, 2013

Conditions

Acute Pancreatitis

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • coagulation related complications

    bleeding for the most coagulative parameters

    14 days after the placement of celiac trunk catheter

  • Pancreatic infection

    28 days

Secondary Outcomes (4)

  • 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

Study Arms (2)

CRAI

EXPERIMENTAL

CRAI of LMWH in the celiac trunk

Procedure: Continuous regional arterial infusion of low molecular weight heparin in celiac trunkOther: General treatment

Conservative treatment

OTHER

Conservative treatment without CRAI, control group

Other: General treatment

Interventions

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

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.

CRAI
General treatmentOTHER

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

CRAIConservative treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Pregnant pancreatitis
  • Receiving surgery or aspiration before;need of early surgery
  • Patients with coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210002, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 20104197BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Weiqin Li, Dr

    Jinling Hospital, School of Medicine, Nanjing University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiqin Li, Dr

CONTACT

+86-025-80860066kkb9832@gmail.com

Zhihui Tong, Dr

CONTACT

+86-025-80860066njzyantol@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of surgical ICU

Study Record Dates

First Submitted

June 16, 2012

First Posted

June 25, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations

CN(1)