An interventional study of blood samples in DIC Syndrome, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
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Evaluation of the use of thromboelastometry for early identification of the underlying coagulopathy and to guide individualized transfusion therapy to prevent DIC development during ICU stay after cesarean section in women with placenta previa who require a massive blood transfusion.
Placenta previa is defined as complete or partial implantation of the placenta in the lower segment of the uterus, Patients present with bleeding per vagina occurring usually in the second and third trimester. Bleeding in placenta previa is associated with maternal morbidity and mortality. Transfusion therapy is integral in the acute management of major obstetric hemorrhage. The most important pregnancy related condition leading to bleeding with high mortality and morbidity rates is DIC. Patients exhibit a tendency for severe bleeding associated with the consumption of platelets and coagulation factors. Massive blood transfusions are listed as the main maternal morbidity indicators6.Therefore, early detection of these predictors of DIC and timely intervention of this life-threatening condition is very important. DIC is a clinical-laboratory diagnosis, and laboratory changes need to be interpreted with knowledge of the patient's underlying disorder. Several laboratory parameters are analyzed together as part of a diagnostic algorithm that includes: Prothrombin time (PT), Activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level, and a marker of fibrin degradation, e.g., D-dimer or the soluble fibrin monomer (SFM) 8. None of these markers are taken in isolation, and a combination of results at different time points is particularly helpful in determining the presence of DIC, owing to the multifaceted nature of DIC9, These reasons highlight a strong need for the development of a point-of-care testing system to accurately and reliably diagnose DIC. Thromboelastography (TEM) provides an extended reflection of clot initiation, propagation, and lysis in whole blood. TEM uses three tests: FIBTEM to reveal impaired fibrinogen function, INTEM to reveal coagulation factor deficiency and EXTEM to reveal extrinsic pathway defects
43 studies on the registry are indexed under Disseminated Intravascular Coagulation; 10 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 18 interventional studies indexed under Disseminated Intravascular Coagulation.
Browse Disseminated Intravascular Coagulation studies →Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention
Other: blood samples
three blood samples : first one pre intervention and the other two blood samples post-intervention
prevention of Postoperative development of DIC
prevention according to the results of thromboelastometry
Time frame: from time of operation till 48 hours postopertive
prevention of Complications of massive transfusion
hypo or hyperkalaemia, hypoc alcaemia, hypothermia and metabolic alkalosis and Length of ICU and hospital stay and In-hospital mortality
Time frame: from time of operation till 48 hours postoperative
Systolic blood pressure
systolic blood pressure is measured every hour from time of operation till 48 hours postoperative
Time frame: from time of operation till 48 hours postoperative
diastolic blood pressure
diastolic blood pressure is measured every hour from time of operation till 48 hours postoperative
Time frame: from time of operation till 48 hours postoperative
heart rate
heart rate is recorded every hour from time of operation till 48 hours
Time frame: from time of operation till 48 hours postoperative
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2017 (actual). Primary completion is estimated for Jun 2020, 34 months after the start.
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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Disseminated Intravascular Coagulation →