Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— CRAI-H  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01626911
• Other study ID #: CRAI-H
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2012
• Last updated: December 6, 2013
• Start date: September 2011

Study information

• Verified date: December 2013
• Source: Nanjing University School of Medicine
• Contact: Weiqin Li, Dr
• Phone: +86-025-80860066
• Email: kkb9832[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

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.

Locations

Country	Name	City	State
China	Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coagulation related complications	bleeding for the most; coagulative parameters	14 days after the placement of celiac trunk catheter	Yes
Primary	Pancreatic infection		28 days	No
Secondary	pancreatic necrosis		28 days	No
Secondary	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.	No
Secondary	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.	No
Secondary	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	No