Purpose: This study was conducted to update the practice guidelines for intravenous infusion therapy published in 2017, focusing on the most recent evidence for peripheral intravenous infusion therapy. Methods: The guideline update was conducted using the 22-step methodology. Results: The updated guidelines consist of 17 domains and 235 recommendations (including 284 sub-recommendations). The domains are as follows: general instructions (5 items), peripheral catheter selection (7), catheter insertion site selection (11), management during peripheral catheter insertion (10), post-insertion management (30), perfusion and locking (17), blood sampling via peripheral catheters(6), exchange and removal of peripheral catheters (6), infusion set management (14), add-on devices (32), complications (25), chemotherapy infusions (10), PCA infusions (7), parenteral nutrition (20), transfusion therapy (23), education (5), and documentation and reporting (7). The evidence levels for these recommendations are as follows: 27(9.5%) at level I, 3 (1.1%) at level I A/P, 118 (41.5%) at level II, and 136 (47.9%) at level III.Recommendation grades are categorized as follows: 30 (10.6%) at level A, 118 (41.5%) at level B, and 136(47.9%) at level C. Of these, 73 (25.7%) recommendations were newly developed, 49 (17.3%) underwent major revisions, and 147 (51.7%) underwent minor revisions. Conclusion The updated practice guideline, based on the latest evidence, is anticipated to enhance nursing practice related to peripheral intravenous infusion therapy.

Purpose: This study was conducted to update the practice guidelines for intravenous infusion therapy published in 2017, focusing on the most recent evidence for peripheral intravenous infusion therapy. Methods: The guideline update was conducted using the 22-step methodology. Results: The updated guidelines consist of 17 domains and 235 recommendations (including 284 sub-recommendations). The domains are as follows: general instructions (5 items), peripheral catheter selection (7), catheter insertion site selection (11), management during peripheral catheter insertion (10), post-insertion management (30), perfusion and locking (17), blood sampling via peripheral catheters(6), exchange and removal of peripheral catheters (6), infusion set management (14), add-on devices (32), complications (25), chemotherapy infusions (10), PCA infusions (7), parenteral nutrition (20), transfusion therapy (23), education (5), and documentation and reporting (7). The evidence levels for these recommendations are as follows: 27(9.5%) at level I, 3 (1.1%) at level I A/P, 118 (41.5%) at level II, and 136 (47.9%) at level III.Recommendation grades are categorized as follows: 30 (10.6%) at level A, 118 (41.5%) at level B, and 136(47.9%) at level C. Of these, 73 (25.7%) recommendations were newly developed, 49 (17.3%) underwent major revisions, and 147 (51.7%) underwent minor revisions. Conclusion The updated practice guideline, based on the latest evidence, is anticipated to enhance nursing practice related to peripheral intravenous infusion therapy.

Purpose: This study was conducted to update the practice guidelines for intravenous infusion therapy published in 2017, focusing on the most recent evidence for peripheral intravenous infusion therapy. Methods: The guideline update was conducted using the 22-step methodology. Results: The updated guidelines consist of 17 domains and 235 recommendations (including 284 sub-recommendations). The domains are as follows: general instructions (5 items), peripheral catheter selection (7), catheter insertion site selection (11), management during peripheral catheter insertion (10), post-insertion management (30), perfusion and locking (17), blood sampling via peripheral catheters(6), exchange and removal of peripheral catheters (6), infusion set management (14), add-on devices (32), complications (25), chemotherapy infusions (10), PCA infusions (7), parenteral nutrition (20), transfusion therapy (23), education (5), and documentation and reporting (7). The evidence levels for these recommendations are as follows: 27(9.5%) at level I, 3 (1.1%) at level I A/P, 118 (41.5%) at level II, and 136 (47.9%) at level III.Recommendation grades are categorized as follows: 30 (10.6%) at level A, 118 (41.5%) at level B, and 136(47.9%) at level C. Of these, 73 (25.7%) recommendations were newly developed, 49 (17.3%) underwent major revisions, and 147 (51.7%) underwent minor revisions. Conclusion The updated practice guideline, based on the latest evidence, is anticipated to enhance nursing practice related to peripheral intravenous infusion therapy.

Purpose: This study was conducted to update the practice guidelines for intravenous infusion therapy published in 2017, focusing on the most recent evidence for peripheral intravenous infusion therapy. Methods: The guideline update was conducted using the 22-step methodology. Results: The updated guidelines consist of 17 domains and 235 recommendations (including 284 sub-recommendations). The domains are as follows: general instructions (5 items), peripheral catheter selection (7), catheter insertion site selection (11), management during peripheral catheter insertion (10), post-insertion management (30), perfusion and locking (17), blood sampling via peripheral catheters(6), exchange and removal of peripheral catheters (6), infusion set management (14), add-on devices (32), complications (25), chemotherapy infusions (10), PCA infusions (7), parenteral nutrition (20), transfusion therapy (23), education (5), and documentation and reporting (7). The evidence levels for these recommendations are as follows: 27(9.5%) at level I, 3 (1.1%) at level I A/P, 118 (41.5%) at level II, and 136 (47.9%) at level III.Recommendation grades are categorized as follows: 30 (10.6%) at level A, 118 (41.5%) at level B, and 136(47.9%) at level C. Of these, 73 (25.7%) recommendations were newly developed, 49 (17.3%) underwent major revisions, and 147 (51.7%) underwent minor revisions. Conclusion The updated practice guideline, based on the latest evidence, is anticipated to enhance nursing practice related to peripheral intravenous infusion therapy.

Background: Pig red blood cells (RBCs) are rapidly eliminated when transfused into nonhuman primates (NHPs) because of immune reactions involving antibody binding and complement activation. We assessed the relationship between post-transfusion hemolysis and complement activation. Methods: RBCs for transfusion were prepared from wild-type (WT) and genetically modified pigs and NHPs. After the withdrawal of 25% of the blood volume, NHPs received transfusions of WT (N = 4), triple knockout (TKO, N = 8), and TKO pig RBCs expressing human CD55 and CD39 (TKO/hCD55.hCD39, N = 4). Additional groups received repeated xenotransfusions (ReXTf, N = 3), NHP RBC transfusions (N = 3), or a saline infusion (N = 4).Blood samples were collected at multiple time points to measure Hb and complement fragment (C3a, C4a, and factor Bb) levels and agglutination titers. Results: Hb levels were restored by transfusions but not by saline infusion. The degree of complement activation varied with the type of transfused RBCs, with significant increases in C3a and factor Bb levels immediately after xenotransfusions but not allotransfusions.These increases were particularly notable in ReXTf and negatively correlated with Hb levels on post-transfusion day 1 (ρ = –0.547 and –0.556; P = 0.0187 and 0.0165, respectively).In TKO/hCD55.hCD39 pig RBC transfusions, C3a and factor Bb peak levels were delayed until post-transfusion day 3, unlike in TKO pig RBC transfusions. Conclusions Post-transfusion complement activation varies depending on prior sensitization and genetic modifications in pig RBCs. Monitoring complement activation can provide insight into the survival and compatibility of transfused RBCs in NHPs.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.