N/A
Completed N=30
Protamine in Cardiac Surgery and Haemostasis
Source: ClinicalTrials.gov NCT01608971 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer — 98; 117; 178; 253 seconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer |
98; 117; 178; 253; 185; 267 | — |
| PRIMARY Rotem MCF Fibtem and MCF Intem |
55; 57; 9; 13 | — |
| SECONDARY Transfusion of Blood Products and Coagulation Factors |
76.7; 80; 20; 60; 20; 60 | — |
| SECONDARY 12 h Postoperative Blood Loss |
620; 723 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01608971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.