In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.

NCT00788255 | Completed Results DMC

• 1 other identifier: SU-10242008-1327
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Oxytocin is normally administered following delivery in pregnant patients to reduce postpartum bleeding by increasing uterine tone. It is unclear whether the use of intravenous oxytocin alters coagulation in pregnant patients. The purpose of the in-vitro study is to assess the coagulation changes of oxytocin in blood samples from pregnant patients using thromboelastrography (TEG). TEG is a point-of-care device which measures the viscoelastic properties of clot formation, and can provide rapid and detailed information about coagulation changes. We aim to collect blood samples from pregnant patients to assess the in-vitro effects of synthetic oxytocin on coagulation using TEG.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (7)

• r Time

  thromboelastographic indices - reaction time (normal range, 5-10 min)

  6 months

• k Time

  thromboelastographic indices - clot formation time (normal range, 1-3 min)

  6 months

• Alpha Angle

  thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)

  6 months

• MA

  thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)

  6 months

• MRTG

  thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)

  6 months

• Tmax

  thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)

  6 months

• TTG

  thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)

  6 months

Study Arms (1)

All participants

For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows: Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.

Drug: Final exogenous oxytocin concentration=22.5 μU/mL; Drug: Final exogenous oxytocin concentration=30.1μU/mL; Drug: Final exogenous oxytocin concentration=32.9μU/mL

Interventions

Final exogenous oxytocin concentration=22.5 μU/mL DRUG

Citrated whole blood 1mL + 23μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.

Also known as: TEG

All participants

Final exogenous oxytocin concentration=30.1μU/mL DRUG

Citrated whole blood 1mL + 31μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.

Also known as: TEG

All participants

Final exogenous oxytocin concentration=32.9μU/mL DRUG

Citrated whole blood 1mL + 34μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.

Also known as: TEG

All participants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy pregnant patients awaiting elective induction of labor or cesarean delivery.

You may not qualify if:

• Patients with significant obstetric or medical disease. No patients \<18 years of age will be recruited.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: NONE RETAINED

Venous blood

Results Point of Contact

• Title: Dr. Alexander Butwick
• Organization: Stanford University School of Medicine

ajbut@stanford.edu

(650) 736-8513

Study Officials

• Alexander J Butwick

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 10, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 28, 2016
• Results First Posted: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)