Clinical Trials Logo
  1. Home
  2. Hemorrhage
  3. NCT03343704

This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding

Hemorrhage Clinical Trial

Official title:
A Phase III, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.

Clinical Trial Summary

The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure. The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03343704
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Completed
Phase Phase 3
Start date March 26, 2018
Completion date July 2, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT02815670 - Reversal Dabigatran Anticoagulant Effect With Idarucizumab Phase 3
Completed NCT04588350 - Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery N/A
Recruiting NCT02972385 - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed NCT02554006 - Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings N/A
Completed NCT02569606 - Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Recruiting NCT02446730 - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Phase 4
Completed NCT01935427 - Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume N/A
Completed NCT01955720 - Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran Phase 1
Recruiting NCT01709786 - Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage N/A
Completed NCT01191554 - Dose-ranging Study of Tranexamic Acid in Valve Surgery N/A
Completed NCT01210417 - Trauma Heart to Arm Time N/A
Completed NCT01136590 - Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery Phase 4
Completed NCT01085006 - The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery Phase 1/Phase 2
Completed NCT00700141 - Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil® N/A
Completed NCT00375466 - Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery. N/A
Completed NCT00147420 - RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet N/A
Completed NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Recruiting NCT05945680 - Tranexamic Acid in Breast Esthetic Surgery. Phase 4
Completed NCT03273322 - Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure Phase 2/Phase 3
Withdrawn NCT05672407 - The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery Phase 4