An interventional study of Rotational Thromboelastometry (ROTEM) in Obstetric Labor Complications and Hemorrhage, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Tampere University Hospital · Not applicable, Interventional, and Treatment
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.
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.
89 studies on the registry are indexed under Obstetric Labor Complications; 25 are open to participants now.
This study's enrollment of 59 is below the median of 150 across 63 interventional studies indexed under Obstetric Labor Complications.
Browse Obstetric Labor Complications studies →Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Rotational thromboelastometry results are used to guide the treatment of major obstetric hemorrhage, eg. administration of prothrombin complex concentrate, fresh-frozen plasma, fibrinogen concentrate or platelets. In case of massive hemorrhage, "shock packs" of blood products in 1:1:1 ratio are administered.
Device: Rotational Thromboelastometry (ROTEM)
Patients are treated according to clinical decision making and conventional coagulation tests, and in case of massive hemorrhage, "shock packs" are administered.
A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.
Reduction in blood transfusions
Time frame: 24 h
Reduction of transfusion related side-effects
Time frame: 30 days
Number of thromboembolic events
Time frame: 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Obstetric Labor Complications→
Tampere University Hospital