NCT00997841

Brief Summary

The purpose of the study is to determine the efficacy of two different algorithms for coagulation management in patients undergoing cardiac surgery suffering from increased bleeding tendency. Algorithm 1 is based on conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration,...) and Algorithm 2 is based on thrombelastometry using the ROTEM-device and impedance aggregometry using the Multiplate device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 4, 2010

Status Verified

October 1, 2009

Enrollment Period

10 months

First QC Date

October 18, 2009

Last Update Submit

May 3, 2010

Conditions

Cardiac SurgeryCoagulation Management

Keywords

POCROTEMMultiplatebleeding tendencycoagulation managementamount of transfused red blood cell concentrates,FFPplatelet concentratesrate of rethoracotomyventilation time

Outcome Measures

Primary Outcomes (1)

  • amount of transfused red blood cell concentrates

    24 h after begin of surgical intervention

Secondary Outcomes (3)

  • other transfused blood products including FFP, platelet concentrates and coagulation factor concentrates

    24h after surgical intervention

  • rate of rethoracotomy for bleeding

    24h after surgical intervention

  • ventilation time on ICU

    till discharge from ICU

Study Arms (2)

POC algorithm

ACTIVE COMPARATOR

cardiac surgery patients suffering from increased perioperative bleeding and being treated following Point of Care based algorithm

Procedure: Point-of-Care versus conventional coagulation management

conventional algorithm

ACTIVE COMPARATOR

cardiac surgery patients suffering from increased perioperative bleeding and being treated following conventional coagulation management algorithm

Procedure: Point-of-Care versus conventional coagulation management

Interventions

Point-of-Care versus conventional coagulation managementPROCEDURE

Patients are randomized to receive either point-of-care based or conventional coagulation measurements based coagulation therapy in the case of increased perioperative bleeding tendency

Also known as: ROTEM, Multiplate, Point-of-Care
POC algorithmconventional algorithm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years, combined surgical procedures (ACB \& valve surgery), double valve surgery, aortic surgery, Re-Dos

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Essen, Clinic for Anesthesiology and Intensive Care Medicine

Essen, 45473, Germany

Location

Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology

Frankfurt am Main, 60590, Germany

Location

Related Publications (4)

  • Görlinger K, Jambor C, Hanke A, Adamzik M, Hartmann M, Rahe-Meyer N. Thrombelastometry and impedance aggregometry based algorithm for coagulation management in cardiac surgery. Intensive Care Med 33: 196, 2007.

    BACKGROUND

  • Görlinger K, Jambor C, Hanke A, Adamzik M, Hartmann M, Rahe-Meyer N. Perioperative coagulation management and controll of platelet transfusion by point-of-care platelet function analysis. Transfus Med Hemother 34: 396-411, 2007.

    BACKGROUND

  • Görlinger K, Bergmann L, Hartmann M, Marggraf G, Kamler M, Müller-Beißenhirtz H. Reduction of blood transfusion rate by thrombelastometry and impedance aggregometry based point-of-care coagulation management in thoracic and cardiovascular surgery. Appl Cardiopulmon Pathophysiol 13: 174-7, 2009.

    BACKGROUND

  • Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644.

    PMID: 22914710DERIVED

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

Point-of-Care Systems

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hospital Information SystemsHospital AdministrationHealth Facility AdministrationOrganization and AdministrationHealth Services AdministrationManagement Information SystemsPatient Care Management

Study Officials

  • Christian F Weber, Dr.

    Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology, Intensive Care Medicine and Pain Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2009

First Posted

October 19, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 4, 2010

Record last verified: 2009-10

Locations

DE(2)