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Platelet Function in Minimal Extracorporeal Circulation in CABG

NCT01935245 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-01-09

No results posted yet for this study

Summary

Rationale:

Cardiac surgery with extracorporeal circulation (ECC) triggers platelets. Minimal extracorporeal circulation system (minimal-ECC) has several advantages compared with conventional ECC amongst less platelet activation. Platelet function can be analysed with thromboelastography (TEG) and multiple electrode aggregometry (MEA).

Objective:

The use of minimal ECC leads to less platelet dysfunction compared with conventional ECC in coronary artery bypass grafting (CABG) analysed with TEG and MEA

Study design:

Single center, prospective, randomized, pilot study

Study population:

Group 1:

20 patients undergoing CABG using minimal ECC. Patients continued the use of acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative.

Group 2:

20 patients undergoing CABG using conventional ECC. Patients continued the use of acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative.

Intervention:

Group 1: CABG using minimal ECC Group 2: CABG using conventional ECC

Main study parameters/endpoints:

1. Results of TEG and MEA, see detailed description
2. Per operative blood loss and total blood loss 24 hours after CABG
3. Total amount of transfused platelet units during CABG and 24 hours after CABG

Conditions

  • Thrombocytopathy

Interventions

DEVICE

Mini extracorporeal circulation

Minimal-ECC versus conventional ECC circuits minimise foreign surface-blood interaction and are heparinized from tip to tip. The tubing length has been shortened to decrease crystalloid prime. Cardiotomy suction is minimised, which leads to less fibrinolysis. An active air-removal device is added to the closed circuit. The use of minimal ECC has already shown a significant reduction of the systemic inflammatory reaction and less peroperative transfusion of blood products.

DEVICE

Conventional extracorporeal circulation

Sponsors & Collaborators

  • Catharina Ziekenhuis Eindhoven

    lead OTHER

Principal Investigators

  • Ingeborg HF Herold, MD · Catharina hospital Eindhoven, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01935245 on ClinicalTrials.gov