Clinical Trials Logo
  1. Home
  2. Obstetric Labor Complications
  3. NCT02461251

Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients — ROTEM-PPH  

Hemorrhage Clinical Trial

Official title:
Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients

Clinical Trial Summary

This is a prospective, randomized and controlled study to find out if a rotational thromboelastometry(ROTEM) guided treatment protocol reduces the need for blood transfusions in major obstetric haemorrhage compared to standard care of clinical decision making, conventional coagulation tests and massive transfusion protocol. Secondary aim is to find out if ROTEM can predict the incidence of thromboembolic events in this patient group.

Clinical Trial Description

A comparison of two different treatment protocols is made in patients suffering major obstetric haemorrhage: those who after a normal delivery are bleeding more than 1000 ml and are in need of surgical intervention to control the bleeding and those in cesarean section with ongoing bleeding of more than 1000 ml. Patients are randomized in to two groups: the control group(n=30) will be treated according to a protocol based on clinical decision making, standard coagulation tests and massive transfusion packages of blood products(1:1:1), if needed. This is referred as 'Standard care' in this hospital. The intervention group(n=30) will be treated according to a rotational thromboelastometry guided protocol, and massive transfusion packages, if needed. The study is powered to detect a reduction of one unit in red blood cell transfusion. Blood product, fibrinogen concentrate, prothrombin complex concentrate usage and total amount of blood loss will be compared, and the number of transfusion related side effects and thromboembolic events 30 days after the bleeding will be recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02461251
Study type Interventional
Source Tampere University Hospital
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date January 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 NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Completed NCT00147420 - RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet N/A
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