Safety and Efficacy of Heparin Dosing Score Protocol for... | NCT03177330

Studies
Safety and Efficacy of Heparin Dosing Score Protocol for Polymyxin-B Hemoperfusion

NCT03177330

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jun 6, 2017Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Septic Shock
Polymyxin B Hemoperfusion

Interventions

Not provided

Countries

Taiwan

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

Jun 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 15, 2017Actual

Primary Completion Date

Jul 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Jun 4, 2017

First Submission Date that Met QC Criteria

Jun 5, 2017

First Posted Date

Jun 6, 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

Jun 5, 2017

Last Update Posted Date

Jun 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Polymyxin B hemoperfusion (PMX-HP) is mainly used to remove endotoxins in septic shock patients with intra-abdominal infections. Because of the concerns of postoperative bleeding, physicians may hesitate to use anticoagulation in patients with septic shock within a few hours after an abdominal operation. We developed a heparin dosing score protocol for heparin dosage adjustment. The purpose of the study is to examine the safety and efficacy of the heparin dosing score protocol.

Detailed Description

Not provided

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
premature cartridge clotting rate	the incidence of premature cartridge clotting within 2hr	2 hours

Secondary Outcomes

Measure	Description	Time Frame
bleeding event rate	the incidence of substantial bleeding event within 24hr	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion in National Taiwan University Hospital during October 2013-December 2016

Exclusion Criteria:

pregnant woman
patients with do-not-resuscitate declaration
uncontrolled bleeding within 24hr

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chen-Tse Lee, MD	Contact	+886972653169		lctbrian314@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, NTUH, Taipei, Taiwan	Recruiting	Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided