Last updated: 11/03/2018 13:53:36

Retrospective study of patients who were treated with fondaparinux pre-, peri- and/or postpartum for prophylaxis or treatment of venous thromboembolismFondaPPP

GSK study ID
112937
See study documents
Clinicaltrials.gov ID
NCT01004939
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Retrospektive Studie zu Patientinnen, die pränatal, perinatal oder postnatal prophylaktisch oder therapeutisch mit Fondaparinux behandelt wurden
Trial description: The objective of this retrospective study is to gather information about how fondaparinux is used pre-, peri- and/or postpartum for both the prophylaxis and treatment of venous thromboembolism (VTE) in order to fill an information gap concerning the off-label use of fondaparinux during pregnancy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants receiving Fondaparinux in the indicated therapy intervals

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with the indicated reason for change to fondaparinux

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants administered the indicated dose of Fondaparinux per day

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Duration of Fondaparinux administration

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Duration of prenatal Fondaparinux administration

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Duration of postnatal Fondaparinux administration

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants for whom Fondaparinux administration was interrupted for birth

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of hours before birth that the Last Fondaparinux dose was administered

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of hours after birth at which Fondaparinux administration was restarted

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with the indicated reason for the end of Fondaparinux administration

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with the indicated outcome of pregnancy by type of birth

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with the indicated type of conception/fertilization

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants who delivered a single child versus twins

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Mean weight of newborn

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Mean height of newborn

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Mean head circumference of newborn

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Mean APGAR Score at 1, 5, and 10 minutes after birth

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of newborns who had a “healthy” postnatal classification

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of newborns with abnormalities

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Secondary outcomes:

Number of participants hospitalized because of thromboembolic treatment

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Duration of all hospitalizations under UFH, LMWH, and Fondaparinux administration

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Duration of hospitalizations before, during, and after Fondaparinux administration

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with complications under UFH/LMWH therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with thromboembolisms under UFH/LMWH therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with bleedings under UFH/LMWH therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with skin changes under UFH/LMWH therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Duration from start of UFH/LMWH therapy to skin change

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants who exhibited observed skin changes and also had erythema associated with the skin changes under UFH/LMWH therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants who exhibited observed skin changes and also had skin necrosis associated with the skin changes under UFH/LMWH therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with heparin-induced thrombocytopenia (HIT II) under UFH/LMWH therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Duration from start of UFH/LMWH therapy to HIT

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with and without complications under Fondaparinux therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with thromboembolisms under Fondaparinux therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with bleedings under Fondaparinux therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with skin changes under Fondaparinux therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Number of participants with heparin-induced thrombocytopenia (HIT II) under Fondaparinux therapy

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Duration from start of Fondaparinux therapy to HIT

Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventions:
  • Drug: fondaparinux
    • Enrollment:
    120
    Primary completion date:
    2010-30-07
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Thromboembolism
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    March 2010 to July 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Patients who were treated with fondaparinux pre-, peri- and/or postpartum for more than 7 days for VTE prophylaxis or treatment, especially those with a history of abortion, and/or stillbirth, VTE, severe fetal and maternal complications during pregnancy, severe inherited or acquired thrombophilias, long-term anticoagulation (e. g. patients with mechanical heart valves) and/or intolerance to heparins or heparinoids or heparin-induced thrombocytopenia (HIT)
    • Patients who were treated with fondaparinux for less than 7 days
    • Patient who were treated with fondaparinux only postpartum
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients who were treated with fondaparinux pre-, peri- and/or postpartum for more than 7 days for VTE prophylaxis or treatment, especially those with a history of abortion, and/or stillbirth, VTE, severe fetal and maternal complications during pregnancy, severe inherited or acquired thrombophilias, long-term anticoagulation (e. g. patients with mechanical heart valves) and/or intolerance to heparins or heparinoids or heparin-induced thrombocytopenia (HIT)
    Exclusion criteria:
    • Patients who were treated with fondaparinux for less than 7 days
    • Patient who were treated with fondaparinux only postpartum

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Leipzig, Sachsen, Germany, 04289
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Frankfurt, Hessen, Germany, 60590
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Duisburg, Nordrhein-Westfalen, Germany, 47051
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Muenster, Nordrhein-Westfalen, Germany, 48143
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mannheim, Baden-Wuerttemberg, Germany, 68167
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13353
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 7 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-30-07
    Actual study completion date
    2010-30-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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