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Bleeding clinical trials

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NCT ID: NCT05672420 Not yet recruiting - Anemia Clinical Trials

Umbilical Cord Derived Mesenchymal Stem Cells for Treatment-induced Myelosuppression in Hematologic Malignancies

Start date: January 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to explore the safety and efficacy of umbilical cord derived mesenchymal stem cells in treatment-induced myelosuppression in patients with hematologic malignancies.

NCT ID: NCT05502809 Not yet recruiting - Trauma Clinical Trials

Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding

MAFOD
Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

Primarily due to its logistical advantages The Netherlands Armed Forces (NLAF) have been successfully using deep frozen (-80°C) platelets (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for effectiveness and safety in the treatment of these type of patients is currently lacking. The MAssive transfusion of Frozen bloOD (MAFOD) trial is therefore designed to compare the haemostatic effect of DTCs versus room temperature stored platelets (RSP) in the treatment of trauma- and vascular bleeding.

NCT ID: NCT05464394 Not yet recruiting - Bleeding Clinical Trials

Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass

PATRY
Start date: September 1, 2022
Phase: Phase 3
Study type: Interventional

The incidence of bleeding after metabolic surgery seems to increase. The administration of a drug (tranexamic acid) that can reduce bleeding could possibly also reduce bleeding after metabolic surgery. Objective: This study aims to determine whether administration of tranexamic acid before surgery can reduce postoperative bleeding in patients undergoing gastric bypass.

NCT ID: NCT04537533 Not yet recruiting - Bleeding Clinical Trials

Tranexamic Acid Infusion in Low Dose Versus in High Dose for Reducing Blood Loss in Radical Cystectomy Operations

Start date: September 2020
Phase: Phase 4
Study type: Interventional

Bladder cancer is one of the most common cancers of the genitourinary tract in adults, and its incidence distinctly increases with age . In almost two-thirds of cases, the disease is superficial at presentation and involves the mucosal and sub mucosal layers or the lamina propria of the bladder, whereas ∼20% to 30% of patients have muscle-invasive tumors. Superficial bladder cancer is treated by transurethral endoscopic resection, which can be followed by endovesical therapy for patients at risk of disease recurrence and progression . In contrast, muscle-invasive bladder cancer is generally treated by radical cystectomy with pelvic lymph node dissection and then creation of urinary diversion to create an alternate route for urine passage, which demonstrates 10-year recurrence-free survival rates of 50% to 59% and overall survival rates of ∼45% . These major surgeries have a prolonged operative times and are associated with significant risk of complications including high risk of perioperative bleeding and subsequent need for blood transfusion with significant postoperative complications, which are reportedly in the range of 24% to 64% .

NCT ID: NCT04315623 Not yet recruiting - Bleeding Clinical Trials

RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk

Start date: March 30, 2020
Phase: N/A
Study type: Interventional

The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.

NCT ID: NCT04229758 Not yet recruiting - Trauma Clinical Trials

Restarting Anticoagulation After Traumatic Intracranial Hemorrhage

Restart tICrH
Start date: October 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: To identify the optimal interval to restart oral anticoagulation after traumatic intracranial hemorrhage that will minimize thrombotic events and major bleeding by performing a response adaptive randomized (RAR) PROBE clinical trial of restarting in anticoagulant-associated traumatic intracranial hemorrhage patients, comparing restart at 1 week to restart at 2 weeks or at 4 weeks, with a primary composite outcome of major thrombotic events and bleeding. Primary Outcome: 60-day composite of thromboembolic events, defined as DVT, pulmonary emboli, myocardial infarctions, ischemic strokes and systemic emboli, and bleeding events defined as non-CNS major bleeding events (modified BARC3 or above) and worsening index tICrH or new intracranial hemorrhage (ICrH). Secondary objectives of this trial include: 1. To use the Trauma Quality Improvement Program (TQIP) of the American College of Surgeons - Committee on Trauma (ACS-COT), a well-established and highly respected trauma center oversight mechanism, to translate findings of the trial into practice in a closed loop. 2. To establish a relationship between time of restarting and overall secondary events, i.e. a dose response, that favors early restarting (1 week is better than 2 weeks and 2 weeks is better than 4 weeks. 3. To explore patient centered utility weighting of thrombotic versus bleeding composite endpoint components by: A) 60-day Disability Rating Scale (DRS) 24,25 and modified Rankin Scale (mRS)26; B) Trial patient-reported standard gamble utilities including by race, gender and ethnicity. 4. To explore the composite without DVT in the thrombotic component

NCT ID: NCT03970213 Not yet recruiting - Bleeding Clinical Trials

Intravenous Tranexamic Acid During Rhytidectomy

Start date: May 30, 2019
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.

NCT ID: NCT03909711 Not yet recruiting - Anemia Clinical Trials

Relationship Between Temperature and Intraoperative Bleeding in Patients Undergoing Multilevel Spinal Surgery

Start date: May 15, 2019
Phase:
Study type: Observational

The primary objective of this multicentric observational study is to define the role of intraoperative temperature decrease (defined as reduction of at least 1 ° C during surgery) as haemorrhagic risk factor, evaluated as reduction of at least 1 gr / dl of hemoglobin, and to correlate it with the need for transfusion. Secondary objectives are infections and complications affecting other organs and systems incidence in the first week after surgery.

NCT ID: NCT03791294 Not yet recruiting - Infection Clinical Trials

Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy ( ISTIAB-0)

ISTIAB-0
Start date: January 1, 2019
Phase: Phase 3
Study type: Interventional

Total hysterectomy is one of the most performed surgical procedures in the world and it is associated with post-operative complications. The postoperative morbidity rate is estimated to vary from 3% to 8% with a readmission rate of 5-7%. The most frequent postoperative complications are urinary tract infections, wound infection of the vaginal vault, vault cellulitis, bleeding, suture dehiscence, pelvic abscess. The introduction of routine antibiotic prophylaxis has significantly reduced the risk of infectious complications, which however remains higher than other "clean" surgery, mainly due to contamination by the vaginal bacterial flora. In this scenario, the introduction of adjuvant factors acting on bacterial flora, can contribute to reduce the risk of post-surgical complications. The cationic silver ions (Ag +) stabilized by covalent link with Titanium dioxide (TiO2), the TIAB, maximizes the properties of silver by optimizing the antibiotic action and disruptive properties of the pathogenic biofilm of bacteria and fungi. Thanks to these properties, TIAB is able to enhance the antibiotic action by reducing the risk of antibiotic resistance and recurrent infections linked to the biofilm. Re-establishing the optimal vaginal microenvironment represents a fundamental step reducing the risk of infections in the surgical site, since the vagina is a non-sterile environment populated by bacterial species that can generate biofilm and potentially infect the site of surgery. In addition to microbicidal and disruptive biofilm activity, TIAB has demonstrated a direct action on tissue regeneration processes by stimulating the production of collagen and its modeling. Different clinical trials have reported a cicatrizing and re-epithelializing action of TIAB administered vaginally in the context of cervical conization for pathology related to HPV. Without showing any notable adverse effects or a negative action on lactobacillary flora with an overall good therapy tolerance by patients. On the basis of the available evidence, the investigators conduct a randomized controlled clinical trial to determine if TIAB treatment in the formulation of vaginal capsules TIAGIN (TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract) is able to reduce the incidence of infectious complications, that are related to altered healing of post-hysterectomy vaginal suture.

NCT ID: NCT03789799 Not yet recruiting - Infection Clinical Trials

Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy

ISTIAB-1
Start date: January 1, 2019
Phase: Phase 3
Study type: Interventional

Total hysterectomy is one of the most performed surgical procedures in the world and it is associated with post-operative complications. The postoperative morbidity rate is estimated to vary from 3% to 8% with a readmission rate of 5-7%. The most frequent postoperative complications are urinary tract infections, wound infection of the vaginal vault, vault cellulitis, bleeding, suture dehiscence, pelvic abscess. The introduction of routine antibiotic prophylaxis has significantly reduced the risk of infectious complications, which however remains higher than other "clean" surgery, mainly due to contamination by the vaginal bacterial flora. In this scenario, the introduction of adjuvant factors acting on bacterial flora, can contribute to reduce the risk of post-surgical complications. The cationic silver ions (Ag +) stabilized by covalent link with Titanium dioxide (TiO2), the TIAB, maximizes the properties of silver by optimizing the antibiotic action and disruptive properties of the pathogenic biofilm of bacteria and fungi. Thanks to these properties, TIAB is able to enhance the antibiotic action by reducing the risk of antibiotic resistance and recurrent infections linked to the biofilm. Re-establishing the optimal vaginal microenvironment represents a fundamental step reducing the risk of infections in the surgical site, since the vagina is a non-sterile environment populated by bacterial species that can generate biofilm and potentially infect the site of surgery. In addition to microbicidal and disruptive biofilm activity, TIAB has demonstrated a direct action on tissue regeneration processes by stimulating the production of collagen and its modeling. Different clinical trials have reported a cicatrizing and re-epithelializing action of TIAB administered vaginally in the context of cervical conization for pathology related to HPV. Without showing any notable adverse effects or a negative action on lactobacillary flora with an overall good therapy tolerance by patients. On the basis of the available evidence, we conduct a randomized controlled clinical trial to determine if TIAB treatment in the formulation of vaginal capsules TIAGIN (TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract) is able to reduce the incidence of infectious complications, that are related to altered healing of post-hysterectomy vaginal suture.