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Preoperative supplementation with fibrinogen concentrate in cardiac surgery: A randomized controlled study
A Jeppsson1, K Waldén2, C Roman-Emanuel3
1Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden anders.jeppsson@vgregion.se.
Insights
Preoperative fibrinogen concentrate supplementation did not reduce postoperative bleeding in cardiac surgery patients without low fibrinogen levels. This study found no significant difference in blood loss or transfusion rates between groups.
Area of Science:
- Cardiovascular Surgery
- Anesthesiology
- Hematology
Background:
- Postoperative bleeding is a significant complication in cardiac surgery.
- Preoperative plasma fibrinogen levels correlate with postoperative blood loss.
- The efficacy of fibrinogen concentrate supplementation to mitigate bleeding requires investigation.
Purpose of the Study:
- To evaluate the effect of preoperative fibrinogen concentrate administration on postoperative bleeding in coronary artery bypass grafting (CABG) patients.
- To determine if fibrinogen supplementation reduces the need for blood product transfusions.
Main Methods:
- A prospective, randomized, double-blind, placebo-controlled trial involving 48 low-risk CABG patients.
- Patients received either 2 g of fibrinogen concentrate or placebo before surgery.
- Primary endpoint was blood loss within 12 hours postoperatively; secondary endpoints included transfusion rates and hemoglobin levels.
Main Results:
- No significant difference in median postoperative bleeding between the fibrinogen and placebo groups (650 ml vs. 730 ml, P=0.29).
- Transfusion proportions (33% vs. 29%, P=0.76) and allogeneic blood product usage were similar between groups.
- Hemoglobin levels at 24 hours post-surgery did not differ significantly (P=0.07).
Conclusions:
- Preoperative fibrinogen concentrate supplementation (2 g) did not significantly reduce postoperative bleeding in CABG patients without preoperative hypofibrinogenemia.
- Fibrinogen supplementation did not impact transfusion requirements or hemoglobin levels in this patient cohort.
Background:
Bleeding remains a severe complication in cardiac surgery. Several studies have found an association between the preoperative plasma concentration of fibrinogen and postoperative bleeding in cardiac surgery patients. This raises the question of whether preoperative supplementation with fibrinogen concentrate can reduce postoperative blood loss.
Methods:
An investigator-initiated, prospective, randomized double-blind placebo-controlled study, was performed in 48 low-risk, coronary artery bypass grafting patients. Subjects were randomized to infusion of 2 g fibrinogen or placebo immediately before surgery, after induction of anaesthesia. The primary endpoint was blood loss during the first 12 h postoperatively. Secondary endpoints included the proportion of transfused subjects, the number of transfused allogeneic blood products (red blood cells, plasma and platelets), and haemoglobin concentration after surgery. Student's t-test and Mann-Whitney U-test was used to compare continuous data and χ(2)-test to compare categorical data between groups.
Results:
Median postoperative bleeding was not significantly different between the fibrinogen and placebo groups [650 (25/75th percentile 500‒835) ml compared with 730 (543‒980) ml, P=0.29]. The proportion of transfused subjects (33 vs 29%, P=0.76), number of perioperative transfusions of allogeneic blood products (0 (0-2 vs 0 (0-3), P=0.76) and haemoglobin concentration 24 h after surgery (107 (sd 11) vs 100 (12) g L-1, P=0.07) were not significantly different between the fibrinogen and placebo group, respectively.
Conclusion:
Preoperative supplementation with 2 g fibrinogen concentrate did not significantly influence postoperative bleeding, in coronary artery bypass grafting patients without documented hypofibrinogenaemia.
Clinical Trial Registration:
NCT 00968045.
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