Protamine in Cardiac Surgery and Haemostasis

NCT01608971 | Completed Results

• 1 other identifier: 007
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bleeding; Hemorrhage

Keywords

Protamine; heparin level; haemostasis; thromboelastometry; cardiac surgery; Patients undergoing cardiac surgery

Outcome Measures

Primary Outcomes (2)

• INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer

  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.

  Tests will be measured 15 minutes after Protamine infusion

• Rotem MCF Fibtem and MCF Intem

  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.

  15 Minutes after protamine infusion

Secondary Outcomes (2)

• Transfusion of Blood Products and Coagulation Factors

  From protamine administration until 12 h after surgery

• 12 h Postoperative Blood Loss

  15 min after protamine administration until 12 hours postoperatively

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• \<18 years
• No informed consent
• Re-do surgery
• Known defect of the coagulation system
• Renal impairment

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Heart & Diabetes Center NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (1)

• Koster A, Borgermann J, Gummert J, Rudloff M, Zittermann A, Schirmer U. Protamine overdose and its impact on coagulation, bleeding, and transfusions after cardiopulmonary bypass: results of a randomized double-blind controlled pilot study. Clin Appl Thromb Hemost. 2014 Apr;20(3):290-5. doi: 10.1177/1076029613484085. Epub 2013 Apr 4.

  PMID: 23564056 RESULT

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

small study cohort

Results Point of Contact

• Title: Andreas Koster
• Organization: Heart and Diabetes Center NRW

akoster@hdz-nrw.de

0043 5731 3284

Study Officials

• Andreas Koster, MD

  Heart & Diabetes Center NRW, Ruhr University Bochum, 32545 Bad Oeynhausen, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior anaestetist

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 27, 2017
• Results First Posted: November 20, 2015

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)