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Hemorrhage clinical trials

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NCT ID: NCT02503319 Withdrawn - Clinical trials for Postpartum Hemorrhage

Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH (TRANOXY2015)

TRANOXY2015
Start date: January 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal delivery ( the bleeding is defined severe if it exceeds 1000 mL). PPH is called "primary" when blood loss arose within 24 hours after birth. This is a open-trial randomized, longitudinal, controlled that including 486 subjects .

NCT ID: NCT02429453 Withdrawn - Clinical trials for Intracranial Hemorrhage, Traumatic

FFP Versus PCC in Intracranial Hemorrhage

Start date: April 2015
Phase: N/A
Study type: Interventional

The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial.

NCT ID: NCT02410655 Withdrawn - Clinical trials for Postpartum Hemorrhage

An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

Start date: November 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.

NCT ID: NCT02303964 Withdrawn - Shock, Hemorrhagic Clinical Trials

Pre-Hospital Use of Plasma for Traumatic Hemorrhage

PUPTH
Start date: November 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal Saline (NS) (standard of care) before arrival at the hospital. The purpose of this study is to determine if prehospital administration of thawed plasma can reduce mortality of patients who have lost a large amount of blood due to their injuries, compared to those receiving standard of care.

NCT ID: NCT02301949 Withdrawn - Clinical trials for Gastrointestinal Vascular Malformation

Retreatment and Its Efficiency of Thalidomide for Vascular Malformation Patients With Failure of First Course Treatment

Start date: December 2015
Phase: Phase 2
Study type: Interventional

Background: Repeated episodes of bleeding from gastrointestinal vascular malformations refractory to endoscopic or surgical therapy often pose a major therapeutic challenge. Methods: The investigators will perform a randomized, double blind, placebo controlled study of thalidomide as a retreatment therapy for recurrent gastrointestinal bleeding due to vascular malformation. Patients with failure of first course treatment of thalidomide will be randomly grouped, prescribed a second four-month course regimen of 25 mg of thalidomide or placebo orally four times daily. All patients will be monitored for at least one year. The primary end point is defined as the patients whose rebleeds decrease from baseline by ≥ 50% at 12 months and the cessation of bleeding. Rebleeding is defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary outcomes include the participants dependent on blood transfusions and changes from baseline in transfused packed red cell units, bleeding episodes, and hemoglobin levels at 12 months. Statistical significance is defined at P < 0.05.

NCT ID: NCT02165644 Withdrawn - Vasospasm Clinical Trials

Carbonic Anhydrase Antagonism in Subarachnoid Hemorrhage

Start date: September 2015
Phase: Phase 2
Study type: Interventional

Subarachnoid Hemorrhage (SAH) can occur commonly in the setting of trauma or brain aneurysm. SAH accounts for 10% of all the strokes. Aneurysmal SAH accounts for 80 % of cases of non-traumatic cases of SAH, 6-8% of all strokes and 22-25% of all cerebrovascular deaths. Mortality can be 50% in the first few years of aneurysmal SAH rupture, 15% are severely disabled post SAH and only 20-35% having a moderate to good recovery it has gained lot of attention and pre-clinical and clinical trials of various agents have been tried to prevent poor outcome. The United States epidemiology data reveals the fact that 1% to 5% of adults have unruptured brain aneurysm and 30,000 people suffer from aneurysm rupture annually translating to brain aneurysm rupture every 18 minutes. Vasospasm is the most common SAH complication post 24 hours. It is the segmental or diffuse narrowing of the vessels especially the large vessels. Fifty percent of those patients who develop clinical vasospasm, progress to infarction and 15-20% will advance to disabling stroke or die of cerebral ischemia. The present treatment modalities are insufficient to prevent vasospasm. So, we need new treatment modalities to decrease the mortality and morbidity in SAH patients. The investigators hypothesize that Acetazolamide administration can prevent development of vasospasm after aneurysmal SAH.

NCT ID: NCT02138175 Withdrawn - Bleeding Clinical Trials

Continuous Hemoglobin Monitoring: Detection of Acute Blood Loss - Accurate, Timely and Cost-effective

Start date: January 2016
Phase:
Study type: Observational

The purpose of the study is to determine whether noninvasive hemoglobin monitoring is sensitive and accurate enough to detect a significant downward trend in hemoglobin in patients at risk for significant bleeding. If this can be shown, it has the potential to spare patients multiple invasive blood draws as well as allow for earlier detection of significant blood loss and therefore positively impact on patient morbidity and mortality. Additionally, it may represent significant financial cost savings in that it may allow for patients to be monitored in a non-intensive care unit setting. This will be an observational study. The continuous hemoglobin monitor will be connected to the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin monitoring will occur concurrently at a pre-specified frequency as well as at the physician's discretion based on usual clinical information. The physician will be blinded to the continuous hemoglobin monitoring readings and therefore patient care will not be affected by the use of the monitor. Once the study has ended, the data will then be analyzed to assess for correlation between continuous hemoglobin monitoring readings and laboratory hemoglobin measurement.

NCT ID: NCT02113176 Withdrawn - Clinical trials for Subarachnoid Aneurysm Hemorrhage

Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage

Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of a drug minocycline in improving outcomes at 3 months after rupture of an aneurysm in the head.

NCT ID: NCT02093182 Withdrawn - Vasospasm Clinical Trials

An Innovative Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm

Start date: n/a
Phase: N/A
Study type: Observational

The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy, highly operator dependent and more. HS-1000 device, an investigational vasospasm detection device, has the potential to safely diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality for vasospasm measurement tool. We aim to evaluate the correlation between the collected and analyzed data from the HS-1000 device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH) patients.

NCT ID: NCT02056574 Withdrawn - Clinical trials for Subarachnoid Hemorrhage

Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms

ENACT-2
Start date: November 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.