Impact of Cardiac Surgery With a Minimal Invasive Extracorporeal Circuit οn Coagulation: Data From Point of Care Devices

NCT04159064 | Completed FDA Device

• 1 other identifier: 49886/8.11.2018
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study includes patients undergoing elective cardiac surgery on MiECC. Coagulation status is assessed with ROTEM (TEM International GmbH, Munich, Germany) and Platelet function with impedance aggregometry using the ROTEM-Platelet (TEM International GmbH, Munich, Germany).

Conditions

Extracorporeal Circulation; Complications; Coagulation Disorder; Extracorporeal Circulation of Blood; Thrombocytopenia

Keywords

extracorporeal circulation; coagulation disorder; Extracorporeal Circulation of Blood; Thrombocytopenia

Outcome Measures

Primary Outcomes (5)

• Change of Clotting Time

  A parameter of the EXTEM and FIBTEM test performed using Rotational Thromboelastometry (ROTEM delta,Tem Systems Inc., Munich, Germany). It is measured in seconds and was tested in two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: after aortic cross clamp off.

  Sample 1: baseline, Sample 2: after aortic cross clamp off

• Change of Maximum Clot Firmness

  A parameter of the EXTEM and FIBTEM test performed using Rotational Thromboelastometry (ROTEM delta,Tem Systems Inc., Munich, Germany). It is measured in millimeters and was tested in two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: after aortic cross clamp off.

  Sample 1: baseline, Sample 2: after aortic cross clamp off

• Change of Clot Formation Time

  A parameter of the EXTEM and FIBTEM test performed using Rotational Thromboelastometry (ROTEM delta,Tem Systems Inc., Munich, Germany). It is measured in seconds and was tested in two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: after aortic cross clamp off.

  Sample 1: baseline, Sample 2: after aortic cross clamp off

• Change of ADPtest of Impedance Aggregometry

  ADPtest was performed using impedance aggregometry. Results expressed with the area under the curve (AUC) and represent the area under the aggregation curve, from the start of the measurement until 6 minutes (test duration). AUC was recorded as Ohm × minutes for each test. Both tests were performed at two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: 20 minutes after heparin reversal.

  Sample 1: baseline, Sample 2': 20 minutes after heparin reversal

• Change of TRAPtest of Impedance Aggregometry

  TRAPtest was performed using impedance aggregometry. Results expressed with the area under the curve (AUC) and represent the area under the aggregation curve, from the start of the measurement until 6 minutes (test duration). AUC was recorded as Ohm × minutes for each test. Both tests were performed at two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: 20 minutes after heparin reversal.

  Sample 1: baseline, Sample 2': 20 minutes after heparin reversal

Secondary Outcomes (7)

• Bleeding in the drainage at 12 hours postoperatively

  12 hours after the end of the procedure

• Bleeding in the drainage at 24 hours postoperatively

  24 hours after the end of the procedure

• Transfusion requirements

  perioperatively and during first 24h in ICU

• Transfusion requirements

  perioperatively and during first 24h in ICU

• Transfusion requirements

  perioperatively and during first 24h in ICU

Study Arms (1)

Minimal Invasive Extracorporeal Circulation(MIECC)

Monitoring coagulation using thromboelastometry and platelet function using impedance aggregometry. Samples at the following phases: Time 0: Baseline, upon arrival at the operation room (samples for thromboelastometry and impedance aggregometry), Time 2: after aortic cross clamp off (only sample for thromboelastometry), Time 2': 20 minutes post protamine administration (only sample for impedance aggregometry ).

Diagnostic Test: Thromboelastometry, Impedance Aggregometry

Interventions

Thromboelastometry, Impedance Aggregometry DIAGNOSTIC_TEST

Study of coagulation changes after cardiac surgery on CPB using Minimal Extracorporeal Circulation

Also known as: Rotational ThromboElastoMetry (ROTEM), ROTEM Platelet

Minimal Invasive Extracorporeal Circulation(MIECC)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting at AHEPA University Hospital for cardiac surgery

You may qualify if:

• elective cardiac surgery

You may not qualify if:

• unwillingness to participate
• preoperative platelet count ≤150 × 109/mm3
• redo surgery
• a known coagulation disorder
• inaccurate documentation of preoperative anti-platelet medication.

Sponsors & Collaborators

• AHEPA University Hospital: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

MeSH Terms

Conditions

Hemostatic Disorders; Thrombocytopenia

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Platelet Disorders; Cytopenia

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Kyriakos Anastasiadis, Prof

  Director of Cardiothoracic Department, AHEPA University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: November 12, 2019
• Study Start: December 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)