Platelet Inhibition and Bleeding in Patients Undergoing N... | NCT01606865

Studies
Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery

NCT01606865

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Oct 23, 2014Estimated

Enrollment

207Actual

Phase

Not provided

Conditions

Postoperative Bleeding

Interventions

Not provided

Countries

Austria

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

May 24, 2012

First Submission Date that Met QC Criteria

May 25, 2012

First Posted Date

May 28, 2012Estimated

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

Oct 22, 2014

Last Update Posted Date

Oct 23, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.

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

Not provided

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

207Actual

Label	Type	Description	Intervention Names
elective and acute non-cardiac surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
increased risk of bleeding (according to TIMI definition)		24hours postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

intake of Clopidogrel, Prasugrel, or Ticagrelor within the last 7 days
spontaneous bleeding or impeding surgery (major vascular surgery, intraperitoneal or intrathoracic surgery, ENT-surgery, orthopedic or trauma surgery, prostatic surgery)

Exclusion Criteria:

concomitant medication with warfarin
renal insufficiency needing dialysis
concomitant therapy with GPIIB/IIIA Antagonists
expected duration of operation >30min

Accepts Healthy Volunteers

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 taking Clopidogrel, Prasugrel, or Ticagrelor within at least 7 days

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helfried Metzler, Prof. Dr.	Medical University of Graz	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Intensive Care Medicine, Medical University Graz		Graz		8036	Austria

Type	Date	Date Unknown
Release	Mar 9, 2020
Reset	Mar 20, 2020

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 9, 2020			Mar 20, 2020

Condition Browse Module

MeSH Terms

ID	Term
D019106	Postoperative Hemorrhage

Ancestor Terms

ID	Term
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided