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Protamine in Cardiac Surgery and Haemostasis (PROTT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608971
First Posted: May 31, 2012
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andreas Koster, Heart and Diabetes Center North-Rhine Westfalia
  Purpose
Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies suggest that an overdose of protamine has anticoagulant effects which might lead to bleeding complications. Heparin levels usually decrease during cardiac surgery with CPB. Therefore, a protamine regimen based on the initial heparin dose before CPB might lead to overdose of protamine. In contrast, a protamine regimen based on the actual heparin concentration may avoid this condition. The investigators compare both regimens of protamine dosing in patients undergoing complex surgery with CPB and assess its effect on the amount of protamine given, markers of the coagulation system, utilization of blood products and perioperative blood loss.

Condition
Bleeding Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Heparin Level Based Versus Weight Based Protamine Dosing on Protamine Demand, Markers of Haemostasis, Blood Product Utilization and Perioperative Blood Loss in Patients Undergoing Extended Cardiac Surgery Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Andreas Koster, Heart and Diabetes Center North-Rhine Westfalia:

Primary Outcome Measures:
  • INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer [ Time Frame: Tests will be measured 15 minutes after Protamine infusion ]
    The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT [seconds](coagulation time), CFT [seconds] (clot formation time) and the CT [seconds] of the HEPTEM test which is non sensitive for residual heparine.

  • Rotem MCF Fibtem and MCF Intem [ Time Frame: 15 Minutes after protamine infusion ]
    The following parameters of the INTEM test will be analyzed: MCF [mm] (maximum clot firmness) which correlates with the platelet count. Furthermore, the MCF [mm] of the FIBTEM test will be analyzed, which correlates with the fibrinogen concentration.


Secondary Outcome Measures:
  • Transfusion of Blood Products and Coagulation Factors [ Time Frame: From protamine administration until 12 h after surgery ]
    The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .

  • 12 h Postoperative Blood Loss [ Time Frame: 15 min after protamine administration until 12 hours postoperatively ]
    The intra and postoperative blood loss from the time point of protamine administration until 12 hours postoperatively will be analyzed.


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Weight based protamine group
In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
Heparin level based protamine group
In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing complex cardiac surgery using cardiopulmonary bypass with mitral valve repair/replacement and 2-4 coronary artery bypass grafting including the left thoracic artery
Criteria

Inclusion Criteria:

  • Primary surgery
  • Preoperative hemoglobin value < 12 g/l
  • Preoperative platelet count < 200 c/µl
  • Patients with a body weight < 50 kg
  • No known defect of the coagulation system
  • Normal pre-operative ROTEM values of the INTEM and FIBTEM
  • Patients with unimpaired renal function (creatinine clearance < 30 ml/kg/min)

Exclusion Criteria:

  • <18 years
  • No informed consent
  • Re-do surgery
  • Known defect of the coagulation system
  • Renal impairment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608971


Locations
Germany
Heart & Diabetes Center NRW
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Investigators
Principal Investigator: Andreas Koster, MD Heart & Diabetes Center NRW, Ruhr University Bochum, 32545 Bad Oeynhausen, Germany
  More Information

Publications:
Responsible Party: Andreas Koster, Senior anaestetist, Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT01608971     History of Changes
Other Study ID Numbers: 007
First Submitted: May 29, 2012
First Posted: May 31, 2012
Results First Submitted: March 17, 2015
Results First Posted: November 20, 2015
Last Update Posted: March 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andreas Koster, Heart and Diabetes Center North-Rhine Westfalia:
Protamine
heparin level
haemostasis
thromboelastometry
cardiac surgery
Patients undergoing cardiac surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Calcium heparin
Heparin
Hemostatics
Protamines
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants
Heparin Antagonists