Acute PancreatitisCRAI-HNCT01626911
Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis
A study testing Continuous regional arterial infusion of low molecular weight heparin in celiac trunk and General treatment in people with Acute Pancreatitis, run by Nanjing University School of Medicine at 1 site in China.
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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Continuous regional arterial infusion of low molecular weight heparin in celiac trunk and General treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnant pancreatitis
- Receiving surgery or aspiration before;need of early surgery
- Patients with coagulation disorders
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
Nanjing, Jiangsu, 210002
Weiqin Li, Dr, +86-025-80860066, kkb9832@gmail.com
Lu Ke, Dr
About this study
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improve global hemodynamics and restore organ function in a porcine model of severe acute pancreatitis (SAP,unpublished).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.
- Conditions
- Acute Pancreatitis
- Being tested
- Continuous regional arterial infusion of low molecular weight heparin in celiac trunk, General treatment
- Keywords
- severe acute pancreatitis;, continuous regional arterial infusion;, low molecular weight heparin
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous regional arterial infusion of low molecular weight heparin in celiac trunkProcedure or surgery
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.
General treatmentOther
Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.
| Study group | Role | What they receive |
|---|---|---|
| CRAI | Experimental | CRAI of LMWH in the celiac trunk Receives: Procedure: Continuous regional arterial infusion of low molecular weight heparin in celiac trunk; Other: General treatment |
| Conservative treatment | Other | Conservative treatment without CRAI, control group Receives: Other: General treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
coagulation related complications
bleeding for the most
coagulative parameters
Measured: 14 days after the placement of celiac trunk catheter
Pancreatic infection
Measured: 28 days
Secondary outcomes (4)
pancreatic necrosis
Measured: 28 days
ICU duration
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiqin Li, Nanjing University School of Medicine
- Investigators
- Weiqin Li, Dr, Principal investigator, Jinling Hospital, School of Medicine, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626911
- Sponsor's protocol ID
- CRAI-H
- Acronym
- CRAI-H
- Status last verified
- Dec 2013
- First submitted
- 16 Jun 2012
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20104197
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01626911
- Acronym / sponsor ID
- CRAI-H / CRAI-H
- Conditions
- Acute Pancreatitis
- Keywords
- severe acute pancreatitis;, continuous regional arterial infusion;, low molecular weight heparin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (estimated)
- First posted
- 25 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRAI | Experimental | Procedure: Continuous regional arterial infusion of low molecular weight heparin in celiac trunk, Other: General treatmentCRAI of LMWH in the celiac trunk |
| Conservative treatment | Other | Other: General treatmentConservative treatment without CRAI, control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnant pancreatitis
- Receiving surgery or aspiration before;need of early surgery
- Patients with coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous regional arterial infusion of low molecular weight heparin in celiac trunkPut 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. | Procedure or surgery | CRAI |
| General treatmentInclude fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc. | Other | CRAI, Conservative treatment |
Primary outcome
coagulation related complications
Time frame: 14 days after the placement of celiac trunk catheter
bleeding for the most coagulative parameters
Pancreatic infection
Time frame: 28 days
4 secondary outcomes
pancreatic necrosis
Time frame: 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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Background: PubMed 20104197Lu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiqin Li, Dr principal investigator
Jinling Hospital, School of Medicine, Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous regional arterial infusion of low molecular weight heparin in celiac trunk and General treatment in people with Acute Pancreatitis, run by Nanjing University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiqin Li, Dr (+86-025-80860066, kkb9832@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coagulation related complications (time frame: 14 days after the placement of celiac trunk catheter). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01626911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.