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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

June 16, 2012
December 6, 2013
September 2011
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • coagulation related complications [ Time Frame: 14 days after the placement of celiac trunk catheter ] [ Designated as safety issue: Yes ]

    bleeding for the most

    cogulative parameters

  • 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 ]
Complete list of historical versions of study NCT01626911 on ClinicalTrials.gov Archive Site
  • 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 ]
  • pancreatic necrosis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Pancreatic infection [ 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 ]
Not Provided
Not Provided
 
Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Pancreatitis
  • 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.
  • Experimental: CRAI
    CRAI of LMWH in the celiac trunk
    Interventions:
    • Procedure: Continuous regional arterial infusion of low molecular weight heparin in celiac trunk
    • Other: General treatment
  • Conservative treatment
    Conservative treatment without CRAI, control group
    Intervention: Other: General treatment
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Weiqin Li, Dr +86-025-80860066 kkb9832@gmail.com
Contact: Zhihui Tong, Dr +86-025-80860066 njzyantol@hotmail.com
China
 
NCT01626911
CRAI-H
No
Weiqin Li, Nanjing University School of Medicine
Nanjing University School of Medicine
Not Provided
Principal Investigator: Weiqin Li, Dr Jinling Hospital, School of Medicine, Nanjing University
Nanjing University School of Medicine
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP