Bleeding Prediction in Patients Following Cardiac Surgery... | NCT01281397

Studies
Bleeding Prediction in Patients Following Cardiac Surgery Using Whole Blood Aggregometry and Thromboelastometry

NCT01281397

Sponsor

University of Zagreb

Status

Terminated

Last Update Posted

Dec 3, 2014Estimated

Enrollment

148Actual

Phase

Not provided

Conditions

Heart Disease
Coronary Artery Disease
Aortic Valve Disease
Mitral Valve Disease

Interventions

Not provided

Countries

Croatia

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

Dec 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

After 148 patients enrolled, interim analysis revealed positive results in regard to primary hypothesis.

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jan 19, 2011

First Submission Date that Met QC Criteria

Jan 20, 2011

First Posted Date

Jan 21, 2011Estimated

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

Dec 1, 2014

Last Update Posted Date

Dec 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Petricevic Mate, Mate Petricevic M.D. , Ph.D., University of ZagrebPrincipal Investigator

Lead Sponsor

University of ZagrebOTHER

Collaborators

Name	Class
Clinical Hospital Centre Zagreb	OTHER
Ministry of Science, Education and Sport, Republic of Croatia	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery.

The purpose of this study is to clarify whether it is possible to predict patients on excessive risk of perioperative bleeding using whole blood impedance aggregometry and rotational thromoelastometry.

Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery disease. Another research goal is to determine the degree of response to antiplatelet therapy before and after surgery and to investigate whether patients by level of response to antiplatelet therapy before surgery have a higher risk of perioperative bleeding.

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

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing elective cardiac surgery		Patients undergoing elective cardiac surgery will be enrolled in study. Data about antiplatelet therapy ingestion prior to surgery will be included.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chest tube output in first 24 hours		24 hours after surgical procedure

Secondary Outcomes

Measure	Description	Time Frame
Allogenic blood products transfusion		7 days after surgery including the day of surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years old
Elective cardiac surgery patients
Coronary artery disease
Aortic valve disease
Mitral valve disease
Ascendent aorta aneurysm
Combine coronary and valve disease
Cardiac surgery procedures using cardiopulmonary bypass

Exclusion Criteria:

Missing consent
Patients with emergent cardiac surgical procedures
Patients on antiplatelet therapy other than aspirin or clopidogrel
Patients with inaccurate antiplatelet therapy administration documentation
Missing data
Off-pump procedures
Patients younger than 18 years old
Patients with severe mental disorders
Intrinsic coagulopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing elective cardiac surgery with cardiopulmonary bypass are enrolled in study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mate Petricevic, M.D.	University hospital center Zagreb- Rebro	Principal Investigator
Bojan Biocina, M.D., Ph.D.	University hospital center Zagreb - Rebro	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital center Zagreb- Rebro		Zagreb	Croatia	10000	Croatia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25231271	Derived	Petricevic M, Biocina B, Milicic D, Svetina L, Boban M, Lekic A, Konosic S, Milosevic M, Gasparovic H. Activated coagulation time vs. intrinsically activated modified rotational thromboelastometry in assessment of hemostatic disturbances and blood loss after protamine administration in elective cardiac surgery: analysis from the clinical trial (NCT01281397). J Cardiothorac Surg. 2014 Sep 17;9:129. doi: 10.1186/1749-8090-9-129.

ID	Term
D006331	Heart Diseases
D003324	Coronary Artery Disease
D000082862	Aortic Valve Disease
D006470	Hemorrhage

ID	Term
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D001161	Arteriosclerosis