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The effect of Plasmaphersis with FFP in Severe Acute Pancreatitis - a Phase 1 Study

Protocol summary

Summary
Acute pancreatitis is an inflammatory disease of pancreas, and can be due to biliary stones, alcohol, trauma, infections, and sometimes it is hereditary. Most of the patients with severe acute pancreatitis will have complications such as shock, sepsis, pulmonary insufficiency, and renal failure which have considerable morbidity and mortality. Severity of pancreatitis and organ damage is dependent to the balance between pro-inflammatory and anti-inflammatory factors. The aim of this study is to measure the effect of plasmapheresis in severe acute pancreatitis, and to assess feasibility of plasmapheresis in these patients and its complications. In this phase I trial we have only one (intervention) group. 15 patients with severe acute pancreatitis, who are admitted to Tabriz Imam Reza Hospital, are included in this study after signing informed consent. Severe acute pancreatitis is diagnosed by Ranson criteria equal or greater than 7. Patients are hospitalized in surgical ICU and standard acute pancreatitis treatments are started. Dialysis catheter is inserted and plasmapheresis with FFP is administered every other day (3 times totally). Plasmapheresis will be discontinued after symptom improvement. Hospital length of stay, ICU length of stay, mortality, pancreatitis complications, blood ESR and CRP, palsmapheresis times, and plasmapheresis complications are documented.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201411084456N1
Registration date: 2014-11-26, 1393/09/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-26, 1393/09/05
Registrant information
Name
Mohammad Bassir Abolghassemi Fakhree
Name of organization / entity
Tabiz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1317
Email address
bassirf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-02-28, 1392/12/09
Expected recruitment end date
2014-08-31, 1393/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Plasmaphersis with FFP in Severe Acute Pancreatitis - a Phase 1 Study
Public title
The effect of Plasmaphersis in Severe Acute Pancreatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: severe acute pancreatitis with ranson score >=7 Exclusion criteria: none
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht St. - Research Affairs
City
Tabriz
Postal code
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
5/4/10443

Health conditions studied

1

Description of health condition studied
severe acute pancreatitis
ICD-10 code
K85.9
ICD-10 code description
Acute Pancreatitis, unspecified

Primary outcomes

1

Description
Pancreatitis complications
Timepoint
at discharge / death
Method of measurement
number

2

Description
mortality
Timepoint
at discharge / death
Method of measurement
number

Secondary outcomes

1

Description
Plasmapheresis coplications
Timepoint
at discharge / death
Method of measurement
number

Intervention groups

1

Description
Dialysis catheter is inserted and plasmapheresis with FFP is administered every other day (3 times totally).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Faculty of Medicine, Research Affairs
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bassir Abolghassemi Fakhree
Position
Assirstant Professor, General Surgeon
Other areas of specialty/work
Street address
Imam Reza Hospital - Dept Surgery
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
BassirF@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bassir Abolghassemi Fakhree
Position
Assistant Professor / General Surgeon
Other areas of specialty/work
Street address
Imam Reza Hospital - Dept. Surgery
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
BassirF@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bassir Abolghassemi Fakhree
Position
Assistant Professor / General Surgeon
Other areas of specialty/work
Street address
Imam Reza Hospital - Dept. General Surgery
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
BassirF@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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