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Perioperative Coagulation Management in Cardiac Surgery.

Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00772239
Acronym
ROTEM
Enrollment
100
Registered
2008-10-15
Start date
2008-10-31
Completion date
Unknown
Last updated
2011-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Cardiac Surgery

Keywords

Coagulation Management, Cardiac surgery, Bleeding, Rotem

Brief summary

Cardiac surgery is bleeding requiring transfusion surgery . The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation. All these changes contribute to increase the need for transfusions during heart surgery. The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests. 100 pateinst (50 in each arm) should be included in this trial.

Interventions

DEVICERotation thromboelastometry (ROTEM)

Coagulation measurement

PROCEDUREStandard coagulation managment procedure

Standard coagulation managment procedure

Sponsors

Laboratoire français de Fractionnement et de Biotechnologies
CollaboratorINDUSTRY
University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults\> 18 years * Cardiac surgery or heart transplantation with abnormal bleeding regardless the etiology * given informed consent

Exclusion criteria

* Patient supported by a pre or postoperative circulatory technical assistance

Design outcomes

Primary

MeasureTime frame
Quantity of different blood transfusionduring cardiac surgery management

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026