Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.

NCT ID: NCT00767832

Last Updated: 2009-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

Detailed Description

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The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). TEG is a point-of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss.

Conditions

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Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at Lucile Packard Hospital who undergo elective Cesarean delivery.
* We will select 100 healthy ASA 1 patients with singleton pregnancies who are scheduled for uncomplicated elective Cesarean delivery, with no anticipated risk of obstetric hemorrhage.

Exclusion Criteria

* Patients with underlying coagulation disorders.
* Patients with thrombocytopenia.
* Patients with pregnancy-induced hypertension, pre-eclampsia.
* Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.
* Patients requiring non-elective Cesarean delivery.
* Patients with significant obstetric or medical disease.
* No patients \<18 years of age will be recruited.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanford University School of Medicine

Principal Investigators

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Alexander J Butwick

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Butwick A, Ting V, Ralls LA, Harter S, Riley E. The association between thromboelastographic parameters and total estimated blood loss in patients undergoing elective cesarean delivery. Anesth Analg. 2011 May;112(5):1041-7. doi: 10.1213/ANE.0b013e318210fc64. Epub 2011 Apr 7.

Reference Type DERIVED
PMID: 21474664 (View on PubMed)

Other Identifiers

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11914

Identifier Type: -

Identifier Source: secondary_id

SU-08252008-1287

Identifier Type: -

Identifier Source: org_study_id

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