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Hemostatic Disorders clinical trials

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NCT ID: NCT02736812 Completed - Shock Hemorrhagic Clinical Trials

Pre-hospital Administration of Lyophilized Plasma for Post-traumatic Coagulopathy Treatment (PREHO-PLYO)

PREHO-PLYO
Start date: April 1, 2016
Phase: Phase 3
Study type: Interventional

In severe bleeding due to trauma, a decrease in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-trauma induced coagulopathy. This study aims to measure the effectiveness of pre-hospital FLYP administration in case of traumatic hemorrhagic shock, in the occurrence or the treatment of a post traumatic induced coagulopathy. Study Design This is a randomized controlled multicenter open label study in two parallel groups. Eligibility criteria : adult, victim of a hemorrhagic shock of traumatic origin with [systolic blood pressure <70 mmHg] or Shock Index >1.1 The patients will receive either FLYP either the usual treatment as given in the recommendations for best practice. The primary endpoint is the International Normalized Ratio (INR) at hospital admission. The study must confirm the link between causality of early administration of plasma in improving post-traumatic coagulopathy. The study must show safe usage in out-of-hospital situations and the ability of medical staff to meet the requirements of the health authorities in terms of product use as well as in terms of traceability of the victims and the treatment they received.

NCT ID: NCT02689232 Completed - Non Variceal Bleed Clinical Trials

TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.

Start date: February 15, 2016
Phase: N/A
Study type: Interventional

All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.

NCT ID: NCT02637427 Completed - Hemorrhage Clinical Trials

Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Start date: February 26, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.

NCT ID: NCT02622126 Completed - Clinical trials for Coagulation Defect; Bleeding

Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia

Start date: January 2016
Phase: Phase 2
Study type: Interventional

Maternal hypotension is the most frequent complication of a spinal Anesthesia. The prevention of spinal hypotension appears more likely to decrease the frequency and severity of associated adverse maternal symptoms than the treatment of established hypotension. Intravenous fluid administration prior to spinal anesthesia for caesarean section is accepted standard practice. The choice of fluid depends on individual and institutional habit, material cost (crystalloid is considerably cheaper) and the perceived relative benefits and risks. Uncommon but potentially serious adverse effect of colloids is impaired coagulation. Although pregnancy is associated with hypercoagulability, little is known about the effects of colloid preloading on coagulation in pregnant patients.

NCT ID: NCT02601053 Completed - Clinical trials for Blood Coagulation Disorder

The Fear F8ctor Study - Does Fear Induce a Blood Curdling State?

FF8
Start date: June 2015
Phase: N/A
Study type: Interventional

For centuries the term "blood curling" has been used to describe extreme frightening situations. However, the origin of this ancient theory has never been studied and it remains unknown if fear induces the coagulation system.The objective was to explore the effects of acute fear on the coagulation system while sitting still. In a crossover study design healthy subjects will be exposed to a horrifying e.g. scary movie followed by a dull e.g. flat movie which is shown at least 1 week after the first movie on the same day of the week at the same time of the day. Participants will be recruited among students from the Leiden University Medical Center. Blood will be drawn from the cubital vein 10 minutes before the first movie, directly after the first movie. The same will be done 10 minutes before and directly after the second movie. Blood is drawn by using a needle puncture. Individual markers of coagulation activity will be determined from the blood samples. Pulse rates will be measured and an anxiety/fear score will be collected from each student for both movies.

NCT ID: NCT02593877 Completed - Trauma Clinical Trials

Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy

iTACTIC
Start date: June 1, 2016
Phase: Phase 2
Study type: Interventional

This trial compares the haemostatic effect of viscoelastic haemostatic assay (VHA)-guided transfusion strategy versus non-VHA guided transfusion strategy in haemorrhaging trauma patients. Half of the randomised patients will receive VHA-led management of bleeding, whilst the other half will receive massive transfusion protocol resuscitation using conventional coagulation tests.

NCT ID: NCT02568202 Completed - Clinical trials for Congenital Bleeding Disorder

Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)

Start date: September 2015
Phase: N/A
Study type: Observational

This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).

NCT ID: NCT02541942 Completed - Clinical trials for Congenital Bleeding Disorder

Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adeptâ„¢2 Trial

Start date: April 3, 2015
Phase: Phase 2
Study type: Interventional

This study is conducted globally. This study describes pharmacogenetic testing of saliva samples from patients who participated in the NN1731-3562 trial (adeptâ„¢2) (NCT01392547). The objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue.

NCT ID: NCT02540005 Completed - Clinical trials for Aneurysmatic Subarachnoid Haemorrhage

Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage

Start date: September 2015
Phase: N/A
Study type: Observational

The main purpose of this study is to analyse the on-going coagulation process after aSAH. For investigation the investigators use the rotational thromboelastometry (ROTEM) which is a point-of-care test using a variety of activators to provide a targeted and a dynamic analysis of coagulation cascade. This is a prospective, observational clinical study done in 16 aSAH patients treated in Tampere University Hospital intensive care unit and 16 control patients (elective craniotomy due to non-ruptured intracranial aneurysm.

NCT ID: NCT02509312 Completed - Postoperative Pain Clinical Trials

Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery

Start date: May 2016
Phase: Phase 4
Study type: Interventional

In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control. Patients will be randomized to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive ketorolac at cord clamp and three additional doses every 6 hours (total 4 doses/24 hours). Those in the placebo group will receive normal saline during those time periods. Our primary outcome is to assess whether intra-operative ketorolac increases the estimated blood loss during Cesarean delivery.