Dataset Information

Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial.

ABSTRACT:

Objective

A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding in cardiac surgery compared with control gauze.

Methods

This was a randomized, controlled, single-blinded study of patients who underwent cardiac surgery between June 2020 and September 2021 across 7 sites with 231 subjects randomized 2:1 to QuikClot Control+ or control. The primary efficacy end point was hemostasis rate (ie, subjects achieving grade 0 bleed) through up to 10 minutes of bleeding site application, assessed using a semiquantitative validated bleeding severity scale tool. The secondary efficacy end point was the proportion of subjects achieving hemostasis at 5 and 10 minutes. Adverse events, assessed up to 30 days postsurgery, were compared between arms.

Results

The predominant procedure was coronary artery bypass grafting, and 69.7% and 29.4% were sternal edge and surgical site (suture line)/other bleeds, respectively. Of the QuikClot Control+ subjects, 121 of 153 (79.1%) achieved hemostasis within 5 minutes, compared with 45 of 78 (58.4%) controls (P < .001). At 10 minutes, 137 of 153 patients (89.8%) achieved hemostasis compared with 52 of 78 controls (68.4%) (P < .001). At 5 and 10 minutes, hemostasis was achieved in 20.7% and 21.4% more QuikClot Control+ subjects, respectively, compared with controls (P < .001). There were no significant differences in safety or adverse events between treatment arms.

Conclusions

QuikClot Control+ demonstrated superior performance in achieving hemostasis for mild to moderate cardiac surgery bleeding compared with control gauze. The proportion of subjects achieving hemostasis was more than 20% higher in QuikClot Control+ subjects at both timepoints compared with controls, with no significant difference in safety outcomes.

SUBMITTER: Mumtaz M

PROVIDER: S-EPMC10328980 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial.

Mumtaz Mubashir M Thompson Richard B RB Moon Marc R MR Sultan Ibrahim I Reece T Brett TB Keeling William B WB DeLaRosa Jacob J

JTCVS open 20230504

<h4>Objective</h4>A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding in cardiac surgery compared with control gauze.<h4>Methods</h4>This was a randomized, controlled, single-blinded study of patients who underwent cardiac surgery between June 2020 and September ...[more]

PMID: 37425449

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Project description:Residual neuromuscular blockade (NMB) is an important and modifiable factor associated with prolonged mechanical ventilation after cardiac surgery. Studies evaluating the use of sugammadex for residual NMB reversal in the post-cardiac surgery ICU setting are lacking. We conducted a randomized trial to determine the efficacy of sugammadex in reducing time to extubation in patients admitted to the ICU after cardiac surgery.DesignSingle-center, randomized, double-blind, placebo-controlled trial.SettingUniversity-based cardiothoracic ICU.SubjectsPatients (n = 90) undergoing elective aortic valve replacement (AVR) and/or coronary artery bypass grafting (CABG) surgery.InterventionsParticipants were randomized to receive either sugammadex (2 mg/kg) or placebo after arrival to the ICU.Measurements and main resultsThe primary study endpoint was time from study drug administration to extubation. Of the 90 patients included in the study (45 in each group), a total of 68 patients underwent CABG, 13 AVR, and nine combined AVR and CABG. Baseline characteristics and intraoperative anesthetic medications were comparable between groups. Patients in sugammadex group had reduced time to extubation compared with the placebo group (median [interquartile range (IQR)]-sugammadex group: 126.0 min [84.0-274.0 min] vs placebo: 219.0 min [121.0-323.0 min]; difference in means [95% CI], 72.8 [1.5-144.1 min]; p = 0.01. There were no differences in negative inspiratory force (mean [sd]-sugammadex group: 33.79 cm H2O [8.39 cm H2O] vs placebo: -31.11 cm H2O [7.17 cm H2O]) and vital capacity (median [IQR]-sugammadex group: 1.1 L [0.9-1.3 L] vs placebo: 1.0 L [0.9-1.2 L]). There were no differences between groups in postoperative blood product requirement, dysrhythmias, length of ICU, or hospital stay. There were no serious adverse events in either group.ConclusionsThis randomized trial showed that the administration of sugammadex after cardiac surgery decreased time to extubation by approximately 1 hour. Larger trials may be required to confirm these findings and determine the clinical implications.

Dataset Information

Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial.

Objective

Methods

Results

Conclusions

Publications

Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial.

Similar Datasets

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