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Fibrinogen; Deficiency, Acquired clinical trials

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NCT ID: NCT05503498 Completed - PHARMACOKINETICS Clinical Trials

Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

PKMF
Start date: January 1, 2021
Phase:
Study type: Observational

characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.

NCT ID: NCT03784794 Completed - Clinical trials for Post Partum Hemorrhage

Patient Blood Management for Massive Obstetric Hemorrhage

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Obstetric Hemorrhage continues to be the first cause of maternal morbidity and mortality around the world especially in middle to low income countriesThe blood components are high value resources; however, its use has been shown to be a risk factor of known complications. The aim of the study is to compare two algorithms of coagulation management in massive obstetric hemorrhage Methods A randomized prospective trial single center two arms study in patients with severe obstetric hemorrhage (PPH > 1000) 2 different transfusion protocols one guided by thromboelastometry and hemostatic drugs (protrombine complex concentrate and fibrinogen concentrate) and the second guided by standard coagulation test and hemocomponents. Sample is calculated to known variance, Analyses are intention-to-treat without imputation, with outcomes will be performed between groups using mixed-effects two level regression models. For binary outcomes, a logistic model will be used and results presented as adjusted odds ratios (ORs) alongside 95% confidence intervals (CIs). Count data will be analysed using Poisson multilevel or negative binomial models. Primary Outcome Parameter: Compare between the two protocols: Number of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall) Secondary Outcome Parameter: Analysis of mortality, lenth of stay admission to the ICU, hysterectomy surgical reintervencion, Transfuse associated circulatory overload, Transfusion associated Acute lung injury, health associated infection will be measured as secondary outcome.

NCT ID: NCT02864875 Completed - Trauma Clinical Trials

Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial

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

This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.