Trial reportAnesthesiology2013
Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial.
Trial report in Anesthesiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00701142 (Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery), which is not on this map. Cited by 74 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
Who cites it
74 citing papers in PubMed, 5 syntheses or guidelines pooled it, 271 citations in OpenAlex.
- Drugs to reduce bleeding and transfusion in major open vascular or endovascular surgery: a systematic review and network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- Transfusion strategies in bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine.Intensive care medicine · 2021Guideline
- Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia.The Cochrane database of systematic reviews · 2018Pooled it
- Effects of restrictive red blood cell transfusion on the prognoses of adult patients undergoing cardiac surgery: a meta-analysis of randomized controlled trials.Critical care (London, England) · 2018Pooled it
- Fibrinogen concentrate in bleeding patients.The Cochrane database of systematic reviews · 2013Pooled it
- Efficacy of fibrinogen concentrate in major abdominal surgery - A prospective, randomized, controlled study in cytoreductive surgery for pseudomyxoma peritonei.Journal of thrombosis and haemostasis : JTH · 2020Trial
- Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy.British journal of anaesthesia · 2016Trial
- Randomized, double-blinded, placebo-controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery.Journal of the American Heart Association · 2015Trial
- Trial
- Fibrinogen concentrate as first-line therapy in aortic surgery reduces transfusion requirements in patients with platelet counts over or under 100×10(9)/L.Blood transfusion = Trasfusione del sangue · 2015Trial
- Time course of haemostatic effects of fibrinogen concentrate administration in aortic surgery.British journal of anaesthesia · 2013Trial
- Does Intraoperative Fibrinogen Affect Blood Loss or Transfusion Practice After Aortic Arch Surgery: A Prematurely Ended Randomized Trial.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisTrial
- Fibrinogen Concentrate in Acute Hemorrhage: Mechanistic Insight, Thresholds, and Targeted Replacement.Journal of clinical medicine · 2026Review
- The Impact of Intraoperative Fibrinogen Replacement Therapy on the Clinical Outcome of Surgical Therapy for Type A Acute Aortic Dissection.Interdisciplinary cardiovascular and thoracic surgery · 2026Article
- Viscoelastic Testing for Coagulation Management in Vascular Surgery-A Narrative Review.Health science reports · 2026Article
- Compliance with ESAIC guidelines for fibrinogen concentrate prescription in cardiac surgery: a multicentre French cohort study.BMC anesthesiology · 2025Observational
- Plasma fibrinogen level and severe bleeding in cardiac surgery: an observational post hoc study of the ALBICS trial.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2025Observational
- Article
- Intraoperative Hemostatic Agents in Thoracic Aortic Surgery-A Scoping Review.Journal of clinical medicine · 2025Review
- 2024 EACTS/EACTAIC Guidelines on patient blood management in adult cardiac surgery in collaboration with EBCP.Interdisciplinary cardiovascular and thoracic surgery · 2025Article
14 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
9 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFibrinogen is suggested to play an important role in managing major bleeding. However, clinical evidence regarding the effect of fibrinogen concentrate (derived from human plasma) on transfusion is limited. The authors assessed whether fibrinogen concentrate can reduce blood transfusion when given as intraoperative, targeted, first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery.
methodsIn this single-center, prospective, placebo-controlled, double-blind study, patients aged 18 yr or older undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to fibrinogen concentrate or placebo, administered intraoperatively. Study medication was given if patients had clinically relevant coagulopathic bleeding immediately after removal from cardiopulmonary bypass and completion of surgical hemostasis. Dosing was individualized using the fibrin-based thromboelastometry test. If bleeding continued, a standardized transfusion protocol was followed.
resultsTwenty-nine patients in the fibrinogen concentrate group and 32 patients in the placebo group were eligible for the efficacy analysis. During the first 24 h after the administration of study medication, patients in the fibrinogen concentrate group received fewer allogeneic blood components than did patients in the placebo group (median, 2 vs. 13 U; P < 0.001; primary endpoint). Total avoidance of transfusion was achieved in 13 (45%) of 29 patients in the fibrinogen concentrate group, whereas 32 (100%) of 32 patients in the placebo group received transfusion (P < 0.001). There was no observed safety concern with using fibrinogen concentrate during aortic surgery.
conclusionsHemostatic therapy with fibrinogen concentrate in patients undergoing aortic surgery significantly reduced the transfusion of allogeneic blood products. Larger multicenter studies are necessary to confirm the role of fibrinogen concentrate in the management of perioperative bleeding in patients with life-threatening coagulopathy.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.