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Bleeding clinical trials

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NCT ID: NCT05711524 Recruiting - Bleeding Clinical Trials

Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding

Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided. Participants will be given one of the two FDA-approved blood products.

NCT ID: NCT05635864 Recruiting - Stroke Clinical Trials

Impact of Catheter Ablation on ABC Risk Scores

CathonABC
Start date: June 3, 2021
Phase:
Study type: Observational

The aim of this prospective, monocentric, non-randomized trial is to investigate the impact of catheter ablation of atrial tachyarrhythmias on the ABC-stroke and ABC-bleeding risk scores. Participants planned for first catheter ablation for symptomatic atrial tachyarrrhythmias (atrial fibrillation, atrial flutter) will be enrolled. Serial blood samples will be collected before and 3, 6 and 12 months after catheter ablation to calculate the ABC scores as well as the traditional bleeding and stroke risks. Following catheter ablation, continuous rhythm monitoring will be achieved using an insertable monitor or an implanted atrial lead of a cardiac implantable electronic device. Additionally, heart rate monitoring via photoplethysmography using a smartwatch and/or smartphone is performed for a period of six months. Data are analyzed for differences in ABC scores before and after ablation in relation to possible AF/AT recurrences. Furthermore, we are going to compare the sensitivity and specificity of different follow-up modalities post ablation. The monitoring via ICM (gold standard) is compared to smartwatch-based monitoring alone, versus smartphone-based monitoring alone or a combination of both for AT/AF recurrences.

NCT ID: NCT05542277 Recruiting - Bleeding Clinical Trials

A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasmaâ„¢) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement

Start date: November 8, 2022
Phase: N/A
Study type: Interventional

Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding. To address this unmet need, PLAS-FREE LTD has developed ClearPlasmaâ„¢, a single-use, extracorporeal plasma filtration device which extracts plasminogen from plasma to reduce fibrinolysis. The resulting plasminogen-depleted plasma (PDP) is expected to reduce risk of fibrinolysis and bleeding in patients undergoing plasma transfusions.

NCT ID: NCT05505591 Recruiting - Clinical trials for Coronary Artery Disease

Intravenous CAngrelor in High-bleeding Risk Patients Undergoing percutaneouS Coronary Intervention (ICARUS) Registry

ICARUS
Start date: June 6, 2022
Phase:
Study type: Observational

The study will investigate the prevalence of high bleeding risk (HBR) features and will compare the clinical outcomes of HBR and non-HBR patients among those undergoing percutaneous coronary intervention and receiving cangrelor infusion.

NCT ID: NCT05391412 Recruiting - Bleeding Clinical Trials

Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery

EFISS
Start date: June 6, 2022
Phase: Phase 4
Study type: Interventional

EFISS is a prospective, randomized, placebo-controlled trial testing the feasibility, safety and efficacy of prophylactic administration of fibrinogen in paediatric spinal surgery. The study is monocentric and will be conducted in University Hospital Brno, Czech Republic. This is a pilot study in which the primary objective will be to evaluate the feasibility of a clinical trial in 32 selected patients undergoing scoliosis surgery. Participants will be randomized into study groups in a 1:1 allocation ratio and followed up for 28 days after surgery. The expected duration of this clinical trial is 8 months.

NCT ID: NCT05380063 Recruiting - Clinical trials for Coronary Artery Disease

Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting

TOP-CABG
Start date: December 1, 2022
Phase: Phase 4
Study type: Interventional

Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting trial (TOP-CABG trial) is a multicenter, randomized, double-blind, non-inferiority, parallel controlled trial. The aim of TOP-CABG is to investigate whether de-escalated dual antiplatelet therapy (De-DAPT) is non-inferior to dual antiplatelet therapy (DAPT) in efficacy on inhibiting great saphenous vein (SVG) graft occlusion and is superior in reducing bleeding events in patients accepting coronary artery bypassing grafting.

NCT ID: NCT05367531 Recruiting - Bleeding Clinical Trials

Assessment of Injectable Medication Platforms

Start date: April 30, 2022
Phase: N/A
Study type: Interventional

Background: While medical advances for in-hospital care rapidly evolve, a mainstay of effective pre-hospital care remains the ability to treat medical emergencies such as anaphylaxis, prolonged seizure, overdose, or uncontrolled bleeding, through rapid administration of appropriate medication. Autoinjectors are used globally to deliver medications in a timely manner, often in environments where immediate access to medical facilities is limited. Rapid administration of intramuscular medication delivery is essential where oral or intravenous delivery is either not possible or ineffective. The purpose of the proposed study seeks to determine the efficiency various types of medication injection administration.

NCT ID: NCT05292846 Recruiting - Clinical trials for Coronary Artery Disease

Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures

DOAC-NOSTOP
Start date: January 20, 2022
Phase: Phase 4
Study type: Interventional

Up to 20-30% of patients who are candidates for direct oral anticoagulation (DOAC) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous coronary intervention (PCI). The decision whether to continue the DOAC throughout periprocedural period or interrupt DOAC before planned procedure represents a substantial challenge in daily clinical practice. The objective of this study is to evaluate the safety of uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures.

NCT ID: NCT05245877 Recruiting - Surgery Clinical Trials

Pre- vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

PREPOSTEROUS2
Start date: August 17, 2022
Phase: Phase 4
Study type: Interventional

Thromboprophylaxis for pancreatic surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. There are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with pancreatic surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in pancreatic surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in pancreatic surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in pancreatic surgery in a randomized controlled trial.

NCT ID: NCT05220787 Recruiting - Bleeding Clinical Trials

Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients

CHASE
Start date: February 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is being performed to evaluate the feasibility of the study protocol and to test the efficacy and safety of platelets stored at cold conditions (1-6°C) in 100% plasma for 10-14 days (CSP) in cardiac surgery patients who are actively bleeding and require platelet transfusion.