Platelet Indices Could Predict Spontaneous Bacterial Peri... | NCT03172013

Studies
Platelet Indices Could Predict Spontaneous Bacterial Peritonitis in Cirrhotic Ascitic Patients

NCT03172013

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

May 31, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cirrhosis, Liver

Interventions

Platelet indices

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 11, 2017Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

May 27, 2017

First Submission Date that Met QC Criteria

May 30, 2017

First Posted Date

May 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2017

Last Update Posted Date

May 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Spontaneous bacterial peritonitis (SBP) is an ascitic fluid infection in cirrhotic patients

Detailed Description

Platelet indices can be utilized as a non-invasive predictor of SBP.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Cirrhotic ascitic patients with SBP,	Cirrhotic ascitic patients with SBP,	Diagnostic Test: Platelet indices
cirrhotic ascitic patients without SBP,	cirrhotic ascitic patients without SBP,	Diagnostic Test: Platelet indices
Healthy volunteers	Healthy individuals	Diagnostic Test: Platelet indices

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet indices	Diagnostic Test	MPV, PDW	Cirrhotic ascitic patients with SBP, Healthy volunteers cirrhotic ascitic patients without SBP,

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with SBP and abnormal platelet indices	Number of patients with SBP and abnormal platelet indices	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cirrhotic patients and ascites

Exclusion Criteria:

patients with ascites due to causes other than cirrhosis- immunocompromised patients,
patients with abnormal thrombocytes due to non-hepatic causes.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with cirrhotic ascites

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, consultant	Contact	00201095159522		Sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Taher Eldemerdash, Professor	Consultant of Hepatology - Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta university hospital	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided