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Completed

NCT Number: NCT01004939

Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism

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.

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Key information

Conditions

Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases Venous Thromboembolism

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site, Mannheim, Baden-Wurttemberg, Germany

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About this study

During pregnancy there is a generally enhanced risk to develop venous thromboembolism (VTE). Although such events are rare they may lead to serious risks for the mothers´ and children´s health. Compared with non-pregnant women, pregnant women have an about five-fold risk to develop VTE.

Due to their characteristic spectrum of side effects and the generally long duration of exposure in pregnancy the preferred anticoagulants may produce potentially dangerous side effects, as bleedings, heparin-induced thrombocytopenia (HIT), allergic reactions, osteoporosis, or congenital anomalies.

Today, low-molecular weight heparins (LMWH) are the preferred agents for anticoagulation in pregnancy. Compared with unfractioned heparins (UFH) LMWHs have the advantages of a lower bleeding risk, a lower rate of allergic reactions and HIT, a more predictable response and a longer half-life that makes dosing more convenient (od or bid).

Still, there is a considerable proportion of pregnancies where heparin intolerance (allergic reactions or HIT) that make it inevitable to change to another anticoagulant.

On the one hand, fondaparinux has repeatedly been reported successful in the VTE prophylaxis of pregnancies where allergic reactions on heparins, or heparinoids, had occurred. Additionally, a considerable amount of oral reports have reached GSK about an additional number of successful cases in the past.

On the other hand, we have no systematic and overall view about how many pregnancies have already been treated for which reasons, and how successful they were. Due to an increase of certain risk factors, as obesity or the growing age of mothers at childbirth with the associated need for anticoagulation, we expect an increased number of cases where alternative anticoagulation to heparins may be needed.

There are a number of potential advantages of fondaparinux over heparins, such as a once daily application, no dose adjustment needed to body weight and no monitoring of thrombocytes, a lower potential for causing intolerance reactions and no risk for HIT.

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 VTE in order to fill an information gap concerning the off-label use of fondaparinux during pregnancy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fondaparinux

Drug

fondaparinux

Primary outcomes

  1. Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals

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

    The prenatal interval is defined as the interval of time until 3 days before birth. The perinatal interval is defined as the interval of time from 2 days before birth to one day after birth. The postnatal interval is defined as the interval of time beginning 2 days after birth.

  2. Number of Participants With the Indicated Reason for Change to Fondaparinux

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

    It was possible for a participant to have changed to fondaparinux for multiple reasons.

  3. Number of Participants Administered the Indicated Dose of Fondaparinux Per Day

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

  4. Duration of Fondaparinux Administration

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

  5. Duration of Prenatal Fondaparinux Administration

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

    The prenatal interval is defined as the interval of time until 3 days before birth.

  6. Duration of Postnatal Fondaparinux Administration

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

    The postnatal interval is defined as the interval of time beginning 2 days after birth.

  7. Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth

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

  8. Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered

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

  9. Number of Hours After Birth at Which Fondaparinux Administration Was Restarted

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

  10. Number of Participants With the Indicated Reason for the End of Fondaparinux Administration

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

    It is possible that a participant stopped receiving Fondaparinux for multiple reasons.

  11. Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth

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

  12. Number of Participants With the Indicated Type of Conception/Fertilization

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

  13. Number of Participants Who Delivered a Single Child Versus Twins

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

  14. Mean Weight of Newborn

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

  15. Mean Height of Newborn

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

  16. Mean Head Circumference of Newborn

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

  17. Mean APGAR Score at 1, 5, and 10 Minutes After Birth

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

    APGAR is a test performed by a doctor, midwife, or nurse at 1 and 5 minutes after birth. The 1-minute score determines how well the baby tolerated the birthing process; the 5-minute score assesses how well the newborn is adapting to the new environment. The health care provider examines the baby's breathing effort, heart rate, muscle tone, reflexes, and skin color. Each category is scored with 0 (worst score), 1, or 2 (best score), depending on the observed condition. The rating is based on a total score of 1-10, with 10 suggesting the healthiest infant.

  18. Number of Newborns Who Had a "Healthy" Postnatal Classification

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

    A "healthy" documentation was based on the investigators' individual assessment.

  19. Number of Newborns With Abnormalities

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

    No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment.

Secondary outcomes

  1. Number of Participants Hospitalized Because of Thromboembolic Treatment

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

    Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism.

  2. Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration

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

  3. Duration of Hospitalizations Before, During, and After Fondaparinux Administration

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

  4. Number of Participants With Complications Under UFH/LMWH Therapy

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

    A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator).

  5. Number of Participants With Thromboembolisms Under UFH/LMWH Therapy

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

    Any sign of thromboembolism as indicated by investigator was measured.

  6. Number of Participants With Bleedings Under UFH/LMWH Therapy

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

    No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.

  7. Number of Participants With Skin Changes Under UFH/LMWH Therapy

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

    No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.

  8. Duration From Start of UFH/LMWH Therapy to Skin Change

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

    No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.

  9. Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy

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

    Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins.

  10. Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy

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

    Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins.

  11. Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy

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

    HIT II is characterized as a sudden decrease of thrombocyte count because of allergic response on heparin/platelet factor 4 (PF-4) complexes and is a severe and potentially fatal side effect of heparins. Usually, HIT occurs between Day 5 and Day 14 of exposure to UFH or LMWH.

  12. Duration From Start of UFH/LMWH Therapy to HIT

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

  13. Number of Participants With and Without Complications Under Fondaparinux Therapy

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

    A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator).

  14. Number of Participants With Thromboembolisms Under Fondaparinux Therapy

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

    Any sign of thromboembolism as indicated by investigator was measured.

  15. Number of Participants With Bleedings Under Fondaparinux Therapy

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

    No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.

  16. Number of Participants With Skin Changes Under Fondaparinux Therapy

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

    No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.

  17. Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy

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

    The participant with HIT II was pretreated with LMWH; however, the serious adverse event of HIT II was documented after the participant switched to Fondaparinux treatment.

  18. Duration From Start of Fondaparinux Therapy to HIT

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

    For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Retrospektive Studie zu Patientinnen, Die pränatal, Perinatal Oder Postnatal Prophylaktisch Oder Therapeutisch Mit Fondaparinux Behandelt Wurden

Acronym: FondaPPP

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 30, 2009
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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