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NCT Number: NCT02972684

Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass

Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac surgical interventions.

Treatment of such complication often necessitates various combinations therapeutic intervention including allogenic blood products administration, drug use and/or surgical intervention. All are expensive treatment and decision making is guided by patient clinical status and biological tests of the haemostatic function.

A key point is the time frame of the clinical process. Therapeutic choices have to be done as fast as possible to minimize bleeding consequences on patient haemodynamic and physiological status. Conventional coagulation test results availability time usually exceed 45' after blood drawing. In such situation, the results may not reflect precisely the coagulation system current state. This downside is often counterbalanced by clinicians empirical choices preceding lab test results knowledge that may conduct to inappropriate treatment, blood product overuse and undue expense.

Viscoelastic point of care test may compensate for the limitations of conventional coagulation tests. In perioperative haemorrhage, faster and more precise information about haemostatic function may help for more accurate therapeutic choices.

The IMOTEC study aims to compare haemorrhage management following cardiac surgery using conventional blood coagulation tests or thrombo-elastogaphic point of care test.

Primary endpoint is a cost utility analysis of the technology and secondary endpoints include blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative infection (any cause), organ failure, in hospital length of stay and death.

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Key information

Conditions

C.Surgical Procedure; Cardiac Blood Coagulation Disorders Blood Transfusion Bypass, Cardiopulmonary Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemostatic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angers University Hospital, Angers, France

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About this study

The research is a real life, prospective, single blinded stepped wedge randomized study.

Inclusion after informed consent of adult patient having cardio-vascular surgical procedure using cardiopulmonary bypass and meeting inclusion criterion "bleeding".

After meeting inclusion criterion patients are managed either using conventional blood coagulation tests or using thrombo-elastometry POC test and predefined therapeutic interventions described in a specific algorithm.

Other elements of patient clinical management follow usual center standard care .

Follow up of EQ-5D and clinical evaluations are performed at one , 6 and 12 months after inclusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Pre-Inclusion Criteria:

  • Adult patients over 18 years old scheduled for elective or urgent cardiac surgery using cardiopulmonary bypass .
  • Patient informed written consent (non-opposition to data use) or person of trust or family member information .

Inclusion criteria

Blood Coagulation test sampling indication for intra or post-operative bleeding defined as follow:

  • intra-operative post CPB bleeding; evaluation more than 10min after heparin reversal by protamin.
  • Clinically significant bleeding judged on surgeon and anesthesiologist consensual point of view
  • Sternal closure delay
  • Chest tube bleeding exceeding 50ml in 10min or more than 1ml/kg in 30min (2ml/kg/h)
  • Postoperative period , evaluation in post operative care environment after 30min stabilization period
  • Chest tube bleeding exceeding 50ml in 10min or more than 1ml/kg in 30min (2ml/kg/h)
  • Patient requiring surgical re-exploration for diagnosed or suspected pericardial effusion or surgical site bleeding requiring surgical hemostatic intervention

Exclusion criteria

  • Known congenital bleeding disorder
  • Redo surgery for patient previously included in the study
  • Implantation of Cardiac support device, Extra Corporeal Membrane Oxygenation (ECMO) Extra Corporeal Life support (ECLS), uni or bi-ventricular artificial hearts.
  • Indication for post-CPB ECMO or ECLS
  • blood transfusion refusal
  • pregnant women
  • patients under 18 years old
  • Adult patient under guardianship, trusteeship or safeguard justice

Treatment and study plan

Thrombo-elastometry POC testing

Device

Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage

Primary outcomes

  1. Cost-utility ratio

    Time frame: one year

    incremental cost per incremental life year and incremental costs per incremental QALY

Secondary outcomes

  1. incremental cost effectiveness ratio

    Time frame: one year

    incremental cost effectiveness ratio : difference in costs divided by the difference in mortality and serious adverse events

  2. Complication rates

    Time frame: one year

    Parameters followed during hospitalization are: volume of postoperative bleeding, allogeneic blood product transfusion, blood cell count, postoperative complications: surgical reexploration, acute kidney injury, need for renal replacement therapy, organ failure, acquired infections, mechanical ventilation duration, intensive care, and in hospital length of stay, death.

  3. Complication rates

    Time frame: one year

    The major complications that can occur within 12 months are: death, cardio-thoracic surgical intervention, acute kidney injury, need for renal replacement therapy, any serious illness diagnosis.

  4. Evaluation survey

    Time frame: Day 1

    Evaluation survey regarding the context and the parameters that impacted the physician's decision, which will be used a sub-group of 100 patients.

  5. The location of the Thrombo-elastometry POC testing

    Time frame: three years

    The location of the Thrombo-elastometry POC testing (operative room or laboratory)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery Using Conventional Blood Coagulation Tests or Thrombo-elastographic Point of Care Test - IMOTEC

Acronym: IMOTEC

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 23, 2016
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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