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

Perfusion ◽  
2017 ◽  
Vol 32 (5) ◽  
pp. 350-362 ◽  
Author(s):  
Idris Ghijselings ◽  
Dirk Himpe ◽  
Steffen Rex

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.

1995 ◽  
Vol 74 (04) ◽  
pp. 1064-1070 ◽  
Author(s):  
Marco Cattaneo ◽  
Alan S Harris ◽  
Ulf Strömberg ◽  
Pier Mannuccio Mannucci

SummaryThe effect of desmopressin (DDAVP) on reducing postoperative blood loss after cardiac surgery has been studied in several randomized clinical trials, with conflicting outcomes. Since most trials had insufficient statistical power to detect true differences in blood loss, we performed a meta-analysis of data from relevant studies. Seventeen randomized, double-blind, placebo-controlled trials were analyzed, which included 1171 patients undergoing cardiac surgery for various indications; 579 of them were treated with desmopressin and 592 with placebo. Efficacy parameters were blood loss volumes and transfusion requirements. Desmopressin significantly reduced postoperative blood loss by 9%, but had no statistically significant effect on transfusion requirements. A subanalysis revealed that desmopressin had no protective effects in trials in which the mean blood loss in placebo-treated patients fell in the lower and middle thirds of distribution of blood losses (687-1108 ml/24 h). In contrast, in trials in which the mean blood loss in placebo-treated patients fell in the upper third of distribution (>1109 ml/24 h), desmopressin significantly decreased postoperative blood loss by 34%. Insufficient data were available to perform a sub-analysis on transfusion requirements. Therefore, desmopressin significantly reduces blood loss only in cardiac operations which induce excessive blood loss. Further studies are called to validate the results of this meta-analysis and to identify predictors of excessive blood loss after cardiac surgery.


2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
J Varma ◽  
R Donovan ◽  
M Whitehouse ◽  
S Kunutsor ◽  
A Blom

Abstract Tranexamic acid (TXA) is an inexpensive, commonly used antifibrinolytic agent that has been shown to significantly reduce perioperative blood loss and transfusion requirements after total hip and knee replacement. We conducted a systematic review and meta-analysis to synthesise the latest evidence regarding the effects of TXA on blood loss in total shoulder replacement (TSR) and total elbow replacement (TER). We systematically searched MEDLINE, EMBASE and CENTRAL from inception to 03 September 2020 for randomised controlled trial (RCTs) and observational studies. Our primary outcome was blood loss, and secondary outcomes included the need for blood transfusion and venous thromboembolic (VTE) complications. Four RCTs and five retrospective cohort studies (RCS) met eligibility criteria for TSRs, but none for TERs. RCT data determined that TXA administration significantly decreased estimated total blood loss, postoperative blood loss, change in haemoglobin (Hb) and total Hb loss when compared to placebo. RCS data demonstrated significant association between TXA administration and decreased in postoperative blood loss, change in Hb, change in Hct and length of stay. This meta-analysis demonstrates that TXA administration in primary TSR significantly decreases blood loss compared with placebo and is associated with lower blood loss and shorter length of stay compared with no treatment with no increase in VTE complications. TXA administration should be part of a wider blood management strategy to minimise perioperative blood loss and blood transfusion requirements in patients undergoing TSR. Further research is needed to demonstrate if a similar treatment benefit exists in patients undergoing TER.


Perfusion ◽  
2003 ◽  
Vol 18 (2) ◽  
pp. 115-121 ◽  
Author(s):  
C R Daane ◽  
H D Golab ◽  
J HJ Meeder ◽  
M J Wijers ◽  
A JJC Bogers

The aim of this prospective randomized study was to compare the effects of the transfusion of unprocessed and cell saver-processed residual cardiopulmonary bypass (CPB) volume on haemostasis, complement activation, postoperative blood loss and transfusion requirements after elective cardiac surgery. Blood samples were taken at eight points in time, perioperatively. Haematological data, including haemoglobin, haematocrit and platelet counts as well as coagulation parameters, including activated partial thromboplastin time, prothrombin time, thrombin time, fibrinogen and the fibrinolytic parameter D-dimers, were measured from each blood sample. For the assessment of complement activation, the total complement CH50 was analysed. In addition, postoperative blood loss and transfusion requirements were measured during the first 24 hours, postoperatively. The results of the study showed impaired haemostasis after the transfusion of both unprocessed and processed CPB volume. No significant differences were found between the groups in the measured coagulation parameters. Nor was a significant difference found in the complement concentration. However, in patients trans-fused with unprocessed CPB volume, a significantly (p = 0.019) higher amount of blood loss was found, postoperatively. In the same group of patients, the number of units of allogeneic erythrocyte concentrate suspension transfused was also significantly (p = 0.023) higher during the first 24 hours, postoperatively, compared to the patients transfused with processed CPB blood. The number of units of fresh frozen plasma and platelet suspension transfused was not significantly different between the groups. In conclusion, processing CPB volume in combination with processing peroperative blood loss may result in reducing the volume of transfusion needed of allogeneic blood products.


1994 ◽  
Vol 22 (5) ◽  
pp. 529-533 ◽  
Author(s):  
M. J. Swart ◽  
P. C. Gordon ◽  
P. B. Hayse-Gregson ◽  
R. A. Dyer ◽  
A. L. Swanepoel ◽  
...  

Fifty patients undergoing primary coronary artery bypass surgery and 50 patients undergoing valve surgery received either high-dose aprotinin (2 million units loading dose, 2 million units added to the CPB prime, and 500,000 units/hr maintenance infusion) or placebo. Mean postoperative blood loss in the first six hours was reduced from 321 ml in the placebo group to 172 ml in the aprotinin group (95% confidence interval (CI) for difference = 95 to 189 ml). Seven patients in the placebo group and 16 patients in the aprotinin group did not require transfusion with homologous blood. This study adds to the growing body of evidence that the administration of high-dose aprotinin reduces blood loss and blood transfusion requirements associated with primary cardiac surgery.


2008 ◽  
Vol 108 (4) ◽  
pp. 596-602 ◽  
Author(s):  
Jose L. Iribarren ◽  
Juan J. Jimenez ◽  
Domingo Hernández ◽  
Maitane Brouard ◽  
Debora Riverol ◽  
...  

Background Plasminogen activator inhibitor 1 (PAI-1) attenuates the conversion of plasminogen to plasmin. Polymorphisms of the PAI-1 gene are associated with varying PAI-1 levels and risk of prothrombotic events in nonsurgical patients. The purpose of this study, a secondary analysis of a clinical trial, was to investigate whether PAI-1 genotype affects the efficacy of tranexamic acid (TA) in reducing postoperative chest tube blood loss of patients undergoing cardiopulmonary bypass. Methods Fifty patients were classified according to PAI-1 genotype (4G/4G, 4G/5G, or 5G/5G). Twenty-four received 2 g TA before and after cardiopulmonary bypass, whereas 26 received placebo. The authors recorded data related to coagulation, fibrinolysis, and bleeding before surgery, at admission to the intensive care unit (0 h), and 4 and 24 h later. Results In patients not receiving TA, those with the 5G/5G genotype had significantly higher chest tube blood loss and transfusion requirements compared with patients with the other genotypes at all time points. Patients with the 5G/5G genotype receiving TA showed significantly lower blood loss compared with the placebo group. There were no significant differences in blood loss or transfusion requirements between patients with the 4G/4G genotype when TA was used. Conclusions Plasminogen activator inhibitor-1 5G/5G homozygotes who did not receive TA showed significantly greater postoperative bleeding than patients with other PAI-1 genotypes. 5G/5G homozygotes who received TA showed the greatest blood-sparing benefit.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Joel Bierer ◽  
David Horne ◽  
Roger Stanzel ◽  
Mark Henderson ◽  
Leah Boulos ◽  
...  

Abstract Background Cardiac surgery with cardiopulmonary bypass (CPB) is associated with a systemic inflammatory syndrome that adversely impacts cardiopulmonary function and can contribute to prolonged postoperative recovery. Intra-operative ultrafiltration during CPB is a strategy developed by pediatric cardiac specialists, aiming to dampen the inflammatory syndrome by removing circulating cytokines and improving coagulation profiles during the cardiac operation. Although ultrafiltration is commonly used in the pediatric population, it is not routinely used in the adult population. This study aims to evaluate if randomized evidence supports the use of continuous intra-operative ultrafiltration to enhance recovery for adults undergoing cardiac surgery with CPB. Methods This systematic review and meta-analysis will include randomized controlled trials (RCT) that feature continuous forms of ultrafiltration during adult cardiac surgery with CPB, specifically assessing for benefit in mortality rates, invasive ventilation time and intensive care unit length of stay (ICU LOS). Relevant RCTs will be retrieved from databases, including MEDLINE, Embase, CENTRAL and Scopus, by a pre-defined search strategy. Search results will be screened for inclusion and exclusion criteria by two independent persons with consensus. Selected RCTs will have study demographics and outcome data extracted by two independent persons and transferred into RevMan. Risk of bias will be independently assessed by the Revised Cochrane Risk-of-Bias (RoB2) tool and studies rated as low-, some-, or high- risk of bias. Meta-analyses will compare the intervention of continuous ultrafiltration against comparators in terms of mortality, ventilation time, ICU LOS, and renal failure. Heterogeneity will be measured by the χ2 test and described by the I2 statistic. A sensitivity analysis will be completed by excluding included studies judged to have a high risk of bias. Summary of findings and certainty of the evidence, determined by the GRADE approach, will display the analysis findings. Discussion The findings of this systematic review and meta-analysis will summarize the evidence to date of continuous forms of ultrafiltration in adult cardiac surgery with CPB, to both inform adult cardiac specialists about this technique and identify critical questions for future research in this subject area. Systematic review registration This systematic review and meta-analysis is registered in PROSPERO CRD42020219309 (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020219309). 


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