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Protamine in Cardiac Surgery and Haemostasis (PROTT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreas Koster, Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier:
NCT01608971
First received: May 29, 2012
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  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
Cardiac Surgery
Cardiopulmonary Bypass

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 With Cardiopulmonary Bypass: A Pilot Investigation

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Intem test of the ROTEM coagulation analyzer [ Time Frame: Intem test will be measured 15 minutes after Protamine infusion ] [ Designated as safety issue: No ]
    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 (coagulation time), CFT (clot formation time) and MCF (maximum clot firmness).


Secondary Outcome Measures:
  • Transfusion of Blood Products and Coagulation Factors [ Time Frame: From protamine administration until 12 h after surgery ] [ Designated as safety issue: No ]
    The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .

  • Perioperative blood loss [ Time Frame: 15 min after protamine administration until 12 hours postoperatively ] [ Designated as safety issue: No ]
    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.

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 29, 2012
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heart and Diabetes Center North-Rhine Westfalia:
Protamine
heparin level
haemostasis
 thromboelastometry
cardiac surgery
Patients undergoing cardiac surgery with cardiopulmonary bypass with mitral valve repair/replacement and 2-4 coronary artery bypass grafting

Additional relevant MeSH terms:
Hemostatics
Heparin
Protamines
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Heparin Antagonists

ClinicalTrials.gov processed this record on May 19, 2013