Clinical trial NCT01004939: Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism
Official title: Retrospektive Studie zu Patientinnen, Die pränatal, Perinatal Oder Postnatal Prophylaktisch Oder Therapeutisch Mit Fondaparinux Behandelt Wurden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolism
Venous Thromboembolism
Keywords: prophylaxis
venous thromboembolism
postpartum
fondaparinux
pregnancy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-30
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who received a prophylaxis against venous thromboembolism because of an elevated thromboembolic risk and who were therefore treated in a haemostaseological centre.

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With the Indicated Reason for Change to Fondaparinux
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Duration of Fondaparinux Administration
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Duration of Prenatal Fondaparinux Administration
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Duration of Postnatal Fondaparinux Administration
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Hours After Birth at Which Fondaparinux Administration Was Restarted
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With the Indicated Reason for the End of Fondaparinux Administration
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With the Indicated Type of Conception/Fertilization
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants Who Delivered a Single Child Versus Twins
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Mean Weight of Newborn
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Mean Height of Newborn
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Mean Head Circumference of Newborn
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Mean APGAR Score at 1, 5, and 10 Minutes After Birth
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Newborns Who Had a "Healthy" Postnatal Classification
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Newborns With Abnormalities
timeFrame: 4 months (all cases occurred between 2004 and 2010)
Secondary outcomes:
measure: Number of Participants Hospitalized Because of Thromboembolic Treatment
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Duration of Hospitalizations Before, During, and After Fondaparinux Administration
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With Complications Under UFH/LMWH Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With Thromboembolisms Under UFH/LMWH Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With Bleedings Under UFH/LMWH Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With Skin Changes Under UFH/LMWH Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Duration From Start of UFH/LMWH Therapy to Skin Change
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: 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)
measure: 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)
measure: Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Duration From Start of UFH/LMWH Therapy to HIT
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With and Without Complications Under Fondaparinux Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With Thromboembolisms Under Fondaparinux Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With Bleedings Under Fondaparinux Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With Skin Changes Under Fondaparinux Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy
timeFrame: 4 months (all cases occurred between 2004 and 2010)
measure: Duration From Start of Fondaparinux Therapy to HIT
timeFrame: 4 months (all cases occurred between 2004 and 2010)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Duisburg
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dempfle CE, Koscielny J, Lindhoff-Last E, Linnemann B, Bux-Gewehr I, Kappert G, Scholz U, Kropff S, Eberle S, Bramlage P, Heinken A. Fondaparinux Pre-, Peri-, and/or Postpartum for the Prophylaxis/Treatment of Venous Thromboembolism (FondaPPP). Clin Appl Thromb Hemost. 2021 Jan-Dec;27:10760296211014575. doi: 10.1177/10760296211014575.