NCT01935245

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

August 28, 2013

Last Update Submit

January 8, 2015

Conditions

Thrombocytopathy

Keywords

Coronary artery bypass graftingExtracorporeal circulationMinimal extracorporeal circulationCoagulopathyThrombocytopathyPlatelet dysfunction

Outcome Measures

Primary Outcomes (1)

  • Platelet function

    Change in thrombocyte function is measured directly after Protamine and three hours after operation. This change is correlated to the reference preoperatively.

    Post-cardiopulmonary bypass

Secondary Outcomes (1)

  • Perioperative blood loss

    24 hours

Other Outcomes (1)

  • Amount of platelet or fresh frozen plasma transfusion

    24 hours

Study Arms (2)

Mini extracorporeal circulation

EXPERIMENTAL

Patients undergoing coronary artery bypass surgery on minimal extracorporeal circulation

Device: Mini extracorporeal circulation

Conventional extracorporeal circulation

ACTIVE COMPARATOR

Patients undergoing coronary artery bypass surgery on conventional extracorporeal circulation

Device: Conventional extracorporeal circulation

Interventions

Mini extracorporeal circulationDEVICE

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.

Also known as: Mini- ECC: ECC.O Oxygenator
Mini extracorporeal circulation
Conventional extracorporeal circulationDEVICE
Also known as: Conventional ECC: D903 Avant Oxygenator
Conventional extracorporeal circulation

Eligibility Criteria

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

You may qualify if:

  • Elective coronary artery bypass grafting
  • Use of acetylsalicylic acid
  • \> 18 years
  • body surface area \< 2.1 \[M2\]

You may not qualify if:

  • Emergency procedures
  • Platelet function disorders
  • Clopidogrel stopped \< 5 days
  • Thrombocytes \< 150/ nanoliter
  • Renal insufficiency, creatinin clearance \<60 ml/min
  • Chronic alcohol abuses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina hospital Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

MeSH Terms

Conditions

Blood Platelet DisordersHemostatic Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagic Disorders

Study Officials

  • Ingeborg HF Herold, MD

    Catharina hospital Eindhoven, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 5, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

NL(1)