Thrombelastometry guided blood-component therapy after cardiac surgery: a randomized study

Abstract Background Significant bleeding is a well known complication after cardiac surgical procedures and is associated with worse outcome. Thrombelastometry (ROTEM®) allows point-of-care testing of the coagulation status but only limited data is available yet. The aim was to evaluate the ROTEM®-guided blood component therapy in a randomized trial. Methods In case of significant postoperative bleeding (> 200 ml/h) following elective isolated or combined cardiac surgical procedures (including 14% re-do procedures and 4% requiring circulatory arrest) patients were randomized to either a 4-chamber ROTEM®-guided blood-component transfusion protocol or received treatment guided by an algorithm based on standard coagulation testing (control). One hundred four patients (mean age: 67.2 ± 10.4 years, mean log. EuroSCORE 7.0 ± 8.8%) met the inclusion criteria. Mean CPB-time was 112.1 ± 55.1 min., mean cross-clamp time 72.5 ± 39.9 min. Results Baseline demographics were comparable in both groups. Overall there was no significant difference in transfusion requirements regarding red blood cells, platelets, plasma, fibrinogen or pooled factors and the re-thoracotomy rate was comparable (ROTEM®: 29% vs. control: 25%). However, there was a trend towards less 24-h drainage loss visible in the ROTEM®-group (ROTEM®: 1599.1 ± 834.3 ml vs. control: 1867.4 ± 827.4 ml; p = 0.066). In the subgroup of patients with long CPB-times (> 115 min.; n = 55) known to exhibit an increased risk for diffuse coagulopathy ROTEM®-guided treatment resulted in a significantly lower 24-h drainage loss (ROTEM®: 1538.2 ± 806.4 ml vs. control: 2056.8 ± 974.5 ml; p = 0.032) and reduced 5-year mortality (ROTEM®: 0% vs. control: 15%; p = 0.03). Conclusion In case of postoperative bleeding following cardiac surgical procedures a treatment algorithm based on “point-of-care” 4-chamber ROTEM® seems to be at least as effective as standard therapy. In patients with long CPB-times ROTEM®-guided treatment may result in less bleeding, a marked reduction in costs and long-term mortality. Trial registration German Clinical Trials Register, TRN: DRKS00017367, date of registration: 05.06.2019, ‘retrospectively registered’.

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Monitoring of hemostasis in cardiac surgical patients: impact of point-of-care testing on blood loss and transfusion outcomes

Clinical Chemistry ◽

10.1093/clinchem/43.9.1684 ◽

1997 ◽

Vol 43 (9) ◽

pp. 1684-1696 ◽

Cited By ~ 96

Author(s):

George J Despotis ◽

J Heinrich Joist ◽

Lawrence T Goodnough

Keyword(s):

Blood Loss ◽

Point Of Care ◽

Coagulation Factor ◽

Surgical Patients ◽

Patient Specific ◽

Blood Component ◽

Multiple Point ◽

Excessive Bleeding ◽

Transfusion Requirements ◽

Increased Risk

Abstract Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) are at increased risk for excessive perioperative blood loss requiring transfusion of blood products. Strategies to optimize administration of heparin and protamine and the assessment of their effects on coagulation are evolving in cardiac surgical patients. Two recent evaluations have focused on the use of multiple point-of-care (POC) coagulation assays for patient-specific adjustment of heparin and protamine dosage. These studies indicate that blood loss and transfusion requirements in cardiac surgical patients may be reduced with more accurate control of heparin anticoagulation and its reversal. Blood component administration in patients with excessive post-CPB bleeding is generally empiric in part, related to turnaround times of laboratory-based tests. Methods are now available for rapid, POC assessment of coagulation to allow appropriate, targeted therapy for acquired hemostatic abnormalities. Recent studies indicate that a rapid evaluation of thrombocytopenia and coagulation factor deficiencies with POC tests can facilitate the optimal administration of pharmacologic and transfusion-based therapy in patients who exhibit excessive bleeding after CPB. POC tests that assess platelet function have been developed, and their use may facilitate identification of which patients at risk for excessive blood loss may respond to pharmacologic interventions such as desmopressin acetate or antifibrinolytic agents.

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The Effect of Antifibrinolytic Prophylaxis on Postoperative Outcomes in Patients Undergoing Cardiac Operations

International Surgery ◽

10.9738/cc75.1 ◽

2012 ◽

Vol 97 (1) ◽

pp. 34-42 ◽

Cited By ~ 1

Author(s):

Abhinav Koul ◽

Victor Ferraris ◽

Daniel L Davenport ◽

Chandrashekhar Ramaiah

Keyword(s):

Blood Transfusion ◽

Postoperative Bleeding ◽

Aminocaproic Acid ◽

Morbidity And Mortality ◽

Antifibrinolytic Agents ◽

Operative Site ◽

Transfusion Requirements ◽

Significant Difference ◽

Multiple Variables ◽

Cardiac Operations

Abstract Antifibrinolytic agents such as aprotinin and epsilon aminocaproic acid limit postoperative bleeding and blood transfusion in patients undergoing cardiac operations using cardiopulmonary bypass (CPB). Recent evidence suggests that these agents have adverse side effects that influence operative mortality and morbidity. We studied postoperative bleeding, transfusion rates, and operative outcomes in our patients in order to assess the efficacy of these agents during cardiac operations requiring CPB. We reviewed records of 520 patients undergoing a variety of cardiac operations between January 2005 and May 2009. We measured multiple variables including pre-operative risk factors, antifibrinolytic agent used, and outcomes of operation, such as measures of bleeding and blood transfusion, as well as serious operative morbidity and mortality. Postoperative bleeding rates varied significantly between patients receiving aprotinin and those receiving aminocaproic acid (P < 0.05). There was an associated 12% decrease in operative site bleeding in aprotinin-treated patients compared with aminocaproic acid. There was no significant difference in the transfusion rates of packed red blood cells between patients receiving aminocaproic acid or aprotinin (P > 0.05), though individuals in the aprotinin group did receive FFP more frequently than patients in the aminocaproic acid group (P < 0.05). There was no significant difference in morbidity and mortality rates between patients in either drug group (P > 0.05). Our study shows that aprotinin is more effective at controlling operative site bleeding than aminocaproic acid. Reduced operative site bleeding did not portend better outcome or differences in transfusion requirements. Aminocaproic acid remains a safe and cost-effective option for antifibrinolytic prophylaxis because of unavailability of aprotinin.

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Predictors of transfusion requirements for cardiac surgical procedures at a blood conservation center

The Annals of Thoracic Surgery ◽

10.1016/s0003-4975(03)01345-6 ◽

2004 ◽

Vol 77 (2) ◽

pp. 626-634 ◽

Cited By ~ 85

Author(s):

David M. Moskowitz ◽

James J. Klein ◽

Aryeh Shander ◽

Katherine M. Cousineau ◽

Richard S. Goldweit ◽

...

Keyword(s):

Surgical Procedures ◽

Cardiac Surgical Procedures ◽

Blood Conservation ◽

Transfusion Requirements

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The Use of Point-of-care Testing in Detecting Platelet Function Recovery in a Patient Treated with Prasugrel Undergoing Urgent Surgical Revascularization

10.22541/au.163251344.48998929/v1 ◽

2021 ◽

Author(s):

Alessandra Verzelloni Sef ◽

Francesca Caliandro ◽

Davorin Sef ◽

Shahzad Raja

Keyword(s):

Platelet Function ◽

Waiting Time ◽

Point Of Care ◽

Artery Bypass ◽

Postoperative Bleeding ◽

Platelet Function Testing ◽

Increased Risk ◽

Function Recovery ◽

Patients At Risk ◽

Function Testing

A recent administration of potent P2Y12 receptor inhibitor such as prasugrel in patients undergoing cardiac surgery remains a dilemma and little is known about its impact on platelet function recovery. Guidelines recommend discontinuation of prasugrel 7 days before surgery to reduce the risk of surgery-related bleeding. Patients at risk may benefit from preoperative platelet function testing to guide individualized preoperative waiting time. We present a rare case of complete function recovery in a patient treated with prasugrel revealed by preoperative platelet function monitoring before urgent coronary artery bypass surgery (CABG). A complete platelet function recovery was revealed by platelet function testing after discontinuation of prasugrel for four days and patient underwent urgent CABG without increased risk of postoperative bleeding. Our case with a review of literature emphasized that the decision to proceed with urgent CABG in a patient recently treated with prasugrel should be based on a personalized risk assessment and might be supported by preoperative platelet function monitoring to shorten the waiting time.

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A Prospective Randomized Clinical Trial of Efficacy of Algorithm-Based Point of Care Guided Hemostatic Therapy in Cyanotic Congenital Heart Disease Surgical Patients

Journal of Cardiac Critical Care TSS ◽

10.1055/s-0039-1696912 ◽

2019 ◽

Vol 03 (01) ◽

pp. 08-16

Author(s):

Ameya Karanjkar ◽

Poonam Malhotra Kapoor ◽

Sandeep Sharan ◽

Vandana Bhardwaj ◽

Vishwas Malik ◽

...

Keyword(s):

Hospital Stay ◽

Point Of Care ◽

Fresh Frozen Plasma ◽

Surgical Patients ◽

Blood Component ◽

Chest Drain ◽

Packed Red Blood Cells ◽

Mechanical Ventilation Duration ◽

Blood Component Therapy ◽

Hemostatic Therapy

Abstract Objective Point of care (POC) testing-based algorithm-guided hemostatic therapy has been used in adult as well as pediatric cardiac surgical patients to administer blood components. The authors hypothesized that implementation of POC-based algorithm in pediatric cyanotic congenital surgical patients would reduce the exposure to blood component therapy and improve the clinical outcome. Design Prospective randomized control trial. Setting Single-center academic institute. Participants One hundred seventy pediatric congenital cyanotic surgical patients. Intervention Implementation of POC and conventional tests-based algorithms. Measurements and Main Results Algorithm-based blood component therapy was administered in each group. There were no group differences regarding the demographic, clinical, and laboratory characteristics. Amount of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, and cryoprecipitate (primary outcomes) administered was significantly lower in POC group than that in the conventional group (p < 0.001). Among the secondary outcomes, the chest drain output at 6, 12, and 24 hours and number of re-explorations was comparable among both the groups. The duration of mechanical ventilation, duration of intensive care unit (ICU) stay, and hospital stay was significantly short in POC group (p = 0.008, <0.001 and 0.019, respectively). Conclusion Implementation of POC-based algorithm-guided hemostatic therapy reduced the exposure to blood and blood component therapy and was associated with reduced ICU and hospital stay in pediatric congenital cyanotic surgical patients.

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Fibrinogen Levels After Cardiac Surgical Procedures: Association With Postoperative Bleeding, Trigger Values, and Target Values

The Annals of Thoracic Surgery ◽

10.1016/j.athoracsur.2016.01.005 ◽

2016 ◽

Vol 102 (1) ◽

pp. 78-85 ◽

Cited By ~ 25

Author(s):

Marco Ranucci ◽

Valeria Pistuddi ◽

Ekaterina Baryshnikova ◽

Dionisio Colella ◽

Paolo Bianchi

Keyword(s):

Surgical Procedures ◽

Postoperative Bleeding ◽

Cardiac Surgical Procedures ◽

Target Values

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Safety of gelatin solutions for the priming of cardiopulmonary bypass in cardiac surgery: a systematic review and meta-analysis

Perfusion ◽

10.1177/0267659116685418 ◽

2017 ◽

Vol 32 (5) ◽

pp. 350-362 ◽

Cited By ~ 6

Author(s):

Idris Ghijselings ◽

Dirk Himpe ◽

Steffen Rex

Keyword(s):

Systematic Review ◽

Cardiac Surgery ◽

Cardiopulmonary Bypass ◽

Blood Loss ◽

Meta Analysis ◽

Postoperative Bleeding ◽

Postoperative Blood Loss ◽

Transfusion Requirements ◽

Significant Difference ◽

Secondary Outcomes

This systematic review and meta-analysis was conducted to evaluate the safety of gelatin versus hydroxyethyl starches (HES) and crystalloids when used for cardiopulmonary bypass (CPB)-priming in cardiac surgery. MEDLINE (Pubmed), Embase and CENTRAL were searched. We included only randomized, controlled trials comparing CPB-priming with gelatin with either crystalloids or HES-solutions of the newest generation. The primary endpoint was the blood loss during the first 24 hours. Secondary outcomes included perioperative transfusion requirements, postoperative kidney function, postoperative ventilation times and length of stay on the intensive care unit. Sixteen studies were identified, of which only ten met the inclusion criteria, representing a total of 824 adult patients: 4 studies compared gelatin with crystalloid, and 6 studies gelatin with HES priming. Only 2 of the studies comparing HES and gelatin reported postoperative blood loss after 24 hours. No significant difference in postoperative blood loss was found when results of both studies were pooled (SMD -0.12; 95% CI: -0.49, 0.25; P=0.52). Likewise, the pooled results of 3 studies comparing gelatin and crystalloids as a priming solution could not demonstrate significant differences in postoperative bleeding after 24 hours (SMD -0.07; 95% CI: -0.40, 0.26; P=0.68). No differences regarding any of the secondary outcomes could be identified. This systematic review suggests gelatins to have a safety profile which is non-inferior to modern-generation tetrastarches or crystalloids. However, the grade of evidence is rated low owing to the poor methodological quality of the included studies, due to inconsistent outcome reporting and lack of uniform endpoint definitions.

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The Utilization of Viscoelastic Testing to Guide Blood Component Therapy and Adjunctive Hemostatic Therapy for Postpartum Hemorrhage: A Narrative Review

Current Opinion in Gynecology and Obstetrics ◽

10.18314/cogo.v2i1.1837 ◽

2019 ◽

pp. 272-286

Author(s):

Baumgartner S ◽

Shariff F ◽

Vande Lune SA ◽

Zackariya N ◽

Grisoli A ◽

...

Keyword(s):

Postpartum Hemorrhage ◽

Point Of Care ◽

Narrative Review ◽

Blood Component ◽

Clinical Parameters ◽

Rotational Thromboelastometry ◽

Coagulation Tests ◽

Blood Component Therapy ◽

History Of ◽

Hemostatic Therapy

This narrative review discusses the history of the pathophysiologic principles and utilization of point-of-care (POC) viscoelastic tests (VETs) in the definition and treatment of postpartum hemorrhage (PPH). This paper addresses the epidemiology of PPH, describes the hemostatic changes that occur in pregnancy and in PPH, and demonstrates the utilization of viscoelastic testing in the identification and treatment of patients with PPH. Additionally, a description of rotational thromboelastometry (ROTEM) and thromboelastography (TEG), the two most commonly used VETs, is detailed in this paper. VETs have only recently been used to guide blood component therapy (BCT) in trauma in the last decade. The recent increased utilization of VETs to guide BCT in PPH is following a similar trend with a delay of ten years. In a similar fashion to the trauma literature, which expanded greatly within this last decade, the literature concerning the use of VETs in PPH has also increased in the last few years. However, because of differing pathophysiologies associated with the coagulopathy of PPH verses traumatic-induced coagulopathy (TIC), utilization of VETs has been more refined and focused on the VETs’ capacity to determine low fibrinogen and to guide the utilization of blood components and prohemostatic agents. The identification and treatment of PPH depends on clinical parameters, conventional coagulation tests (CCTs) including Clauss fibrinogen, and VETs. Successful treatment of PPH will no doubt include utilization of all three strategies with an increasing utilization of VETs in the future.

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Assessment of endogenous fibrinolysis using a point-of-care assay to identify increased cardiovascular risk in patients with diabetes and ACS

European Heart Journal ◽

10.1093/ehjci/ehaa946.1540 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

R Kanji ◽

Y.X Gue ◽

D Dinarvand ◽

M.Q Farag ◽

D.A Gorog

Keyword(s):

Whole Blood ◽

Clinical Characteristics ◽

Thrombus Formation ◽

Point Of Care ◽

Occlusion Time ◽

Increased Risk ◽

Significant Difference ◽

Patients With Diabetes ◽

Endogenous Fibrinolysis ◽

Point Of Care Assay

Abstract Introduction Patients with diabetes mellitus (DM) are increased risk of myocardial infarction (MI) and following a MI, patients with DM have an increased risk of recurrent MI and cardiovascular (CV) death. Plasma turbidimetry studies show that hypofibrinolysis is a key abnormality in DM that may drive increased ischaemic risk. Such assays are cumbersome, require specialist expertise and do not provide information in a clinically-relevant timeframe. Assessment of fibrinolysis in whole blood, using a point-of-care assay, has revealed that in ACS patients, impaired fibrinolysis is predictive of adverse CV events. Whether this technique can identify residual risk in patients with DM, is unclear. Purpose It was our aim to compare thrombotic and endogenous fibrinolytic status between patients with and without DM, presenting with ACS. Methods We conducted a prospective, observational study of consecutive patients admitted with ACS. Venous blood was taken to assess thrombotic and thrombolytic status using the point-of-care Global Thrombosis Test, assessing time to occlusive thrombus formation under high shear (occlusion time, OT) and time taken for spontaneous lysis of the thrombus (lysis yime, LT). Blood was taken after dual antiplatelet therapy (DAPT) loading, but before administration of fondaparinux or low molecular weight heparin. Patients with renal or hepatic impairment, known bleeding diathesis, thrombocytopenia and those taking anticoagulation were excluded. Results A total of 775 patients were included, of whom 158 (20%) had DM. Patients with DM, compared to those without DM, more frequently had hypertension (70% vs. 39%, p<0.001), hyperlipidaemia (65% vs. 29%, p<0.001), higher BMI (28.6 [25.3–32.0] vs. 26.6 [23.7–29.8] kg/m2, p<0.001) and prior MI (28% vs 9%, p<0.001), but were less often smokers (23% vs. 34% p=0.007). In all other clinical characteristics DM and non-DM patients were matched. Time to occlusive thrombus formation was similar in patients with and without DM (OT 401 (284–519) s vs. 391 (289–514) s, p=0.603). There was a trend for longer LT in patients with DM compared to those without DM (LT 1634 (130–2321) s vs. 1562 (1247–2147) s, p=0.080). After propensity score matching to adjust for baseline differences in clinical characteristics, we observed a highly significant difference in LT between DM and non-DM patients (LT 1634 [1306–2321] s vs. 1387 [1109–1740] s, p<0.001). Patients with DM also had higher fibrinogen level (4.4 [3.5–5.4] vs. 4.1 [3.5–4.8] g/l, p=0.012) and higher C-reactive protein (5 [2–12] vs. 3 [1–8] mg/l, p=0.002). CRP correlated with LT (r=0.2, p=0.016), but no correlation was observed between fibrinogen and LT (r=0.069, p=0.424). Conclusions Amongst patients with ACS, those with DM exhibit markedly impaired endogenous fibrinolysis compared to those without DM, and this can be detected with a bedside assay using whole blood. This may explain the increased risk of secondary events in patients with ACS and DM. Funding Acknowledgement Type of funding source: None

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PREVENTION OF DEEP VEIN THROMBOSIS (DVT) AFTER TOTAL HIP REPLACEMENT (THR) by ENOXAPARINE (LOVENOXR) : ONE DAILY INJECTION OF 40 MG VERSUS TWO DAILY INJECTIONS OF 20 MG

10.1055/s-0038-1643214 ◽

1987 ◽

Author(s):

A PLANES ◽

N VOCHELLZ ◽

C MANSAT

Keyword(s):

Lower Limbs ◽

Daily Injection ◽

Bleeding Complications ◽

Double Blind ◽

Vein Thrombosis ◽

Transfusion Requirements ◽

Increased Risk ◽

Significant Difference ◽

Group B ◽

Present Trial

Venous thromboembolism is a common complication in patients undergoing THR. In a previous open study, Enoxaparine, a low-molecular-weight-heparin, in a dose of 40 mg/24 hrs by SC injection, had been shown to be efficient in preventing DVT in these patients. This treatment was not associated with an increased risk of bleeding. The present trial compares the efficiency and the risks of bleeding of two regimens : treatment A (2 daily subcutaneous (SC) injections of 20 mg of Enoxaparine) and treatment B (1 daily SC injection of 40 mg of Enoxaparine).118 patients, over 40 years, with a non traumatic hip disease, requiring THR, were included in a randomized, double blind trial. 59 patients received the treatment A. 59 patients received the treatment B. In both groups administration of 40 mg of Enoxaparine was begun 12 hours before operation. Patients were treated for 12-15 days, until bilateral ascending phlebography (BAP) had been completed.Lower limbs BAP were performed in 114 patients. The frequency of DVT is low and is not significantly different between the two regimens : a DVT was detected in 1 of 57 patients who received the treatment A and in 6 of 57 patients who received the treatment B (p = 0.11) . No pumonary embolism occurred in the 114 patients.There was no serious bleeding complication, and the two groups are not significantly different on this point. 3 patients in each group had an important hematoma of the thigh. None required a surgical treatment. Red cell transfusion requirements were 3.88 U ± 1.71 in the group A and 3.5 3 U ± 1.06 in the group B (p = 0.20). There was no significant difference in daily hemoglobin levels between the two groups.One daily injection of 40 mg of Enoxaparine was as effective as two daily SC injections of 20 mg of Enoxaparine in preventing DVT, in patients undergoins THR. The frequencies of bleeding complications were the same in each group.Enoxaparine (LOVENOXR) - PHARMUKA S.F.

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