- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01626911
Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis (CRAI-H)
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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210002
- Recruiting
- Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
-
Contact:
- Weiqin Li, Dr
- Phone Number: +86-025-80860066
- Email: kkb9832@gmail.com
-
Sub-Investigator:
- Lu Ke, Dr
-
Sub-Investigator:
- Luyao Zhang, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CRAI
CRAI of LMWH in the 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.
Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.
|
Other: Conservative treatment
Conservative treatment without CRAI, control group
|
Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
coagulation related complications
Time Frame: 14 days after the placement of celiac trunk catheter
|
bleeding for the most coagulative parameters |
14 days after the placement of celiac trunk catheter
|
Pancreatic infection
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pancreatic necrosis
Time Frame: 28 days
|
28 days
|
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.
|
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
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.
|
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
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
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Weiqin Li, Dr, Jinling Hospital, School of Medicine, Nanjing University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRAI-H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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