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Point-of-Care Testing in Coagulopathic Patients Undergoing Cardiac Surgery - a Multicenter Study (MultiPOC)

G

Goethe University

Status

Unknown

Conditions

Coagulopathy During Cardiac Surgery

Treatments

Device: Conventional laboratory testing (Central laboratory)
Device: POC testing

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Recently, the investigators study group showed in a mono center study that Point of Care (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in perioperative care of coagulopathic cardiac surgery patients. The investigators aim to verify the obtained results by conducting this multicenter study.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Step 1:

  • Patients scheduled for elective, complex cardiothoracic surgery (combined coronary artery bypass graft and valve surgery, double or triple valve procedures, aortic surgery or redo surgery) with cardiopulmonary bypass (CPB)

Step 2:

  • diffuse bleeding after heparin reversal following extracorporeal circulation or
  • intra- or postoperative blood loss exceeding 250 ml/h or 50 ml/10 min

Exclusion criteria

  • Pregnancy

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Conventional laboratory testing
Active Comparator group
Description:
After being randomized to the group "conventional coagulating testing", hemostatic therapy will be based exclusively on conventional standard coagulation analyses like International normalized ratio (INR), activated prothrombin time (aPTT), fibrinogen and platelet concentration or Activated clotting time (ACT. Analyses will be performed at i) fixed time points (preoperative and at admission to ICU) and ii) variable timepoints depending on the decision of the attending physician. Hemostatic therapy will be based on a specific hemostatic therapy algorithm. Intraoperatively, analyses of ACT (activated clotting time) and INR will be performed following institutional standards using specific POC tests.
Treatment:
Device: Conventional laboratory testing (Central laboratory)
POC testing (ROTEM and Multiplate)
Active Comparator group
Description:
After being randomized to the group "POC testing", hemostatic therapy will be based exclusively on POC measures obtained by i) viscoelastic tests (ROTEM(R), TEM international, Munich, Germany) and aggregometric tests (multiplate, ROCHE AG, Grenzach, Germany). Analyses will be performed at variable timepoints depending on the decision of the attending physician. Hemostatic therapy will be based on a specific hemostatic therapy algorithm. Intraoperatively, analyses of ACT (activated clotting time) and INR will be performed following institutional standards using specific POC tests.
Treatment:
Device: POC testing

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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