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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Nanjing University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Weiqin Li, Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01626911
First received: June 16, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).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


Condition Intervention
Acute Pancreatitis
Procedure: Continuous regional arterial infusion of low molecular weight heparin in celiac trunk
Other: General treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • coagulation related complications [ Time Frame: 14 days after the placement of celiac trunk catheter ] [ Designated as safety issue: Yes ]

    bleeding for the most

    coagulative parameters


  • Pancreatic infection [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pancreatic necrosis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Conservative treatment
Conservative treatment without CRAI, control group
Other: General treatment
Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626911

Contacts
Contact: Weiqin Li, Dr +86-025-80860066 kkb9832@gmail.com
Contact: Zhihui Tong, Dr +86-025-80860066 njzyantol@hotmail.com

Locations
China, Jiangsu
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Weiqin Li, Dr    +86-025-80860066    kkb9832@gmail.com   
Sub-Investigator: Lu Ke, Dr         
Sub-Investigator: Luyao Zhang, Dr         
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Principal Investigator: Weiqin Li, Dr Jinling Hospital, School of Medicine, Nanjing University
  More Information

Publications:
Responsible Party: Weiqin Li, Director of surgical ICU, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01626911     History of Changes
Other Study ID Numbers: CRAI-H
Study First Received: June 16, 2012
Last Updated: December 6, 2013
Health Authority: China: Ministry of Health

Keywords provided by Nanjing University School of Medicine:
severe acute pancreatitis;
continuous regional arterial infusion;
low molecular weight heparin

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014