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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01626911
Acronym
CRAI-H
Enrollment
60
Registered
2012-06-25
Start date
2011-09-30
Completion date
Unknown
Last updated
2013-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Keywords

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

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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).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

Interventions

PROCEDUREContinuous 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.

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

Sponsors

Nanjing University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
coagulation related complications14 days after the placement of celiac trunk catheterbleeding for the most coagulative parameters
Pancreatic infection28 days

Secondary

MeasureTime frame
pancreatic necrosis28 days
ICU durationParticipants 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 durationParticipants 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.
MortalityParticipants will be followed until the date of discharge or the date of death from any cause, whichever came first, assessed up to 3 months

Countries

China

Contacts

Primary ContactWeiqin Li, Dr
kkb9832@gmail.com+86-025-80860066
Backup ContactZhihui Tong, Dr
njzyantol@hotmail.com+86-025-80860066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026