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Surgical Blood Loss clinical trials

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NCT ID: NCT04588350 Completed - Hemorrhage Clinical Trials

Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery

i-TRANSEP
Start date: September 28, 2020
Phase: N/A
Study type: Interventional

Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous or autotransfusion method (which is done with the patient's own blood). Although homologous transfusions can save lives, it can cause significant adverse events. Since then, multiple solutions have been developed to avoid exposing patients to these risks. It is in this context that was born the "Patient Blood Management" (PBM). Thus, the strategy in this PBM has been defined as "the appropriate use of blood and blood components, with the aim of minimizing the use of allogeneic transfusions". In this context, particular interest has been given to autologous transfusion or autotransfusion or cell salvage, the general purpose is to reduce (or even stop) the use of allogeneic products and to reduce the risks associated with the ABO compatibility system, as well as all the adverse effects associated with allogeneic plasma and platelet transfusions. Most autotransfusers available on the market operate by centrifugation. Autotransfusion is already a solution in Patient Blood Management and its efficiency and safety have already been optimized. However, there is still a need to improve the quality of the treated blood with an easier-to-use device that could improve the quality of the blood concentrate. Indeed, with the current devices, it may happen that the use of allogeneic transfusions, plasma and platelets transfusions, is necessary in addition to autologous red blood cells thus reducing the interest of autotransfusion. It is in this context that i-SEP has developed a new autotransfusion device based on a filtration method. Unlike competing devices, the i-SEP device allows the concentration of not only red blood cells (as competitive devices) but also platelets. In this study, the i-SEP device is used in typical clinical applications of autotransfusion: cardiovascular and orthopedic surgeries, where there is a risk of hemorrhage and/or blood loss for example ≥ 500mL in cardiac surgery and ≥ 300mL in orthopedic surgery. The study includes a screening phase (≤ 21Days), surgery phase when the i-SEP device is used (Day 0), a post-surgery phase (Day 1 - Day 6), a first follow-up visit (Day 7 ± 3) and a second follow-up visit (Day 30 ± 7).

NCT ID: NCT04143373 Completed - Surgical Blood Loss Clinical Trials

Effect of Warm Saline Irrigation on Bleeding in Mandibular Third Molar Surgery

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively.

NCT ID: NCT04040023 Completed - Surgical Blood Loss Clinical Trials

Patient Blood Management in Cardiac Surgery

PBMc
Start date: September 10, 2019
Phase: N/A
Study type: Interventional

Preoperative anemia is associated with an important increase in transfusions of red blood cells (RBC) compared to a non-anemic patient in cardiac and non cardiac surgery. Furthermore transfusion is also an independent factor of morbi-mortality with notably an increase in the infectious risk, immunological, an increase of the risk of cardiac decompensation, respiratory decompensation Transfusion Related Acute Lung Injury (TRALI) or Transfusion Associated Cardiac Overload (TACO), and an increase in mortality of 16%. Management of perioperative transfusion is therefore a public health issue. Since 2010, the World Health Organization (WHO) has been promoting a systematic approach to implement blood management programs for the patient to optimize the use of resources and promote quality and safety of care. Improving the relevance of transfusion in cardiac surgery could be achieved by optimizing the management of patients around 2 axis: A:non-drug intervention : Review of Practices to Improve the Management of Perioperative RBC Transfusion B:drug intervention : Systematic correction of pre- and postoperative iron, vitamin deficiencies and anemia The aim of this program is to improve the relevance of transfusion in cardiac surgery and to limit the morbidity and mortality induced by transfusion. This program is part of a global project of pre, per and postoperative management of the patient undergoing cardiac surgery programmed under extracorporeal circulation (ECC). It requires a multidisciplinary approach between cardiologists, anesthesiologists and intensivists, perfusionists, cardiac surgeons and paramedical teams to optimize the management of the patient.

NCT ID: NCT04025736 Completed - Rotator Cuff Tears Clinical Trials

Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

Start date: June 7, 2017
Phase: N/A
Study type: Interventional

Purpose: The study aimed to determine whether intravenous administration of tanexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity. Methods: This is a prospective, double-blinded, randomized and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group that received 1000mg tranexamic acid intravenously 10 minutes before surgery or the placebo group that received the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anti-coagulation medications were excluded. The visual clarity was rated by a numeric rating scale from grade 1(poor) to grade 3(clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration and associated comorbidities were recorded. Both parametric and nonparametric methods were used for statistical analysis.

NCT ID: NCT03991481 Active, not recruiting - Hemorrhage Clinical Trials

The Cryopreserved vs. Liquid Platelets Trial

CLIP II
Start date: August 17, 2021
Phase: Phase 3
Study type: Interventional

This trial is a phase III multicentre blinded randomised controlled clinical non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of surgical bleeding. The aim of the study is to assess the efficacy, safety and cost effectiveness of cryopreserved platelets, compared to conventional liquid-stored platelets, for the management of surgical bleeding. This trial will recruit cardiac surgical patients deemed to be at high risk of surgical bleeding and who may potentially require transfusion of platelets. It is estimated to require 808 high-risk cardiac surgical patients to be recruited, to obtain 202 patients who receive transfused study platelets for surgical bleeding.

NCT ID: NCT03984851 Completed - Surgical Blood Loss Clinical Trials

Hemostasis Using Surgicel in Pediatric Tonsillectomy

Start date: January 1, 2016
Phase:
Study type: Observational

Tonsillectomy is one of the commonest procedures performed in otolaryngology and one of its major complications is post-tonsillectomy bleeding. The goal of this study was to assess the effectiveness of Surgicel without bipolar cautery in achieving primary hemostasis in tonsillectomy. The patient that were enrolled in this retrospective study were patients who underwent tonsillectomy and achieved hemostasis either by Surgicel (group A) or bipolar cautery (group B). Our results showed that there was no statistical significant difference between the two techniques in terms of post-operative bleeding events.

NCT ID: NCT03954314 Terminated - Bleeding Clinical Trials

DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

DEPOSITION
Start date: September 17, 2019
Phase: Phase 3
Study type: Interventional

The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.

NCT ID: NCT03952546 Completed - Surgical Blood Loss Clinical Trials

To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty

Start date: May 7, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether the saline-coupled bipolar sealer compared to the unipolar electrocautery provides superior hemostasis in patients undergoing primary unilateral total knee arthroplasty. This will be a prospective, randomized, single-blinded, non-inferiority study in patients scheduled for a primary unilateral total knee arthroplasty (TKA) with Dr. Eugene Krauss or Dr. Ayal Segal. The restriction of this study to two surgeons will limit variations in the outcomes being measured due to differences in surgical technique.

NCT ID: NCT03740438 Recruiting - Surgery Clinical Trials

Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course

Start date: September 1, 2018
Phase:
Study type: Observational [Patient Registry]

transfusion-related decisions in the perioperative setting are often complex due to acute variations in the hemoglobin levels, which typically experience a progressive decrease within days. This process, commonly referred to as "hemoglobin drop" or "hemoglobin drift", has been observed to be highly variable among patients and reliant on several variables, such as the volemic status, fluid balance and blood loss. Although it has been investigated and some predictors have been identified, postoperative hemoglobin drop remains unpredictable and is not fully clarified. In consequence, hemoglobin levels' variations are frequently misunderstood, hindering the decision to transfuse.

NCT ID: NCT03476707 Completed - Surgery Clinical Trials

Association of Anemia With Hospital Costs in Elective Colorectal Surgery

Start date: January 2010
Phase:
Study type: Observational

The objective is to measure the adjusted association between preoperative anemia and total hospital costs. We hypothesize that patients with anemia before surgery will have higher hospitalization costs than people without anemia.