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

Venous Thromboembolism Clinical Trial

— FondaPPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004939
• Other study ID #: 112937
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: July 28, 2011
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: July 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• fondaparinux
fondaparinux

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bonn	Rheinland-Pfalz
Germany	GSK Investigational Site	Duisburg	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals	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.	4 months (all cases occurred between 2004 and 2010)	No
Primary	Number of Participants With the Indicated Reason for Change to Fondaparinux	It was possible for a participant to have changed to fondaparinux for multiple reasons.	4 months (all cases occurred between 2004 and 2010)	No
Primary	Number of Participants Administered the Indicated Dose of Fondaparinux Per Day		4 months (all cases occurred between 2004 and 2010)	No
Primary	Duration of Fondaparinux Administration		4 months (all cases occurred between 2004 and 2010)	No
Primary	Duration of Prenatal Fondaparinux Administration	The prenatal interval is defined as the interval of time until 3 days before birth.	4 months (all cases occurred between 2004 and 2010)	No
Primary	Duration of Postnatal Fondaparinux Administration	The postnatal interval is defined as the interval of time beginning 2 days after birth.	4 months (all cases occurred between 2004 and 2010)	No
Primary	Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth		4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered		4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Number of Hours After Birth at Which Fondaparinux Administration Was Restarted		4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Number of Participants With the Indicated Reason for the End of Fondaparinux Administration	It is possible that a participant stopped receiving Fondaparinux for multiple reasons.	4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth		4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Number of Participants With the Indicated Type of Conception/Fertilization		4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Number of Participants Who Delivered a Single Child Versus Twins		4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Mean Weight of Newborn		4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Mean Height of Newborn		4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Mean Head Circumference of Newborn		4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Mean APGAR Score at 1, 5, and 10 Minutes After Birth	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.	4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Number of Newborns Who Had a "Healthy" Postnatal Classification	A "healthy" documentation was based on the investigators' individual assessment.	4 months (all cases occurred between 2004 and 2010)	Yes
Primary	Number of Newborns With Abnormalities	No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants Hospitalized Because of Thromboembolic Treatment	Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration		4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Duration of Hospitalizations Before, During, and After Fondaparinux Administration		4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With Complications Under UFH/LMWH Therapy	A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator).	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With Thromboembolisms Under UFH/LMWH Therapy	Any sign of thromboembolism as indicated by investigator was measured.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With Bleedings Under UFH/LMWH Therapy	No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With Skin Changes Under UFH/LMWH Therapy	No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Duration From Start of UFH/LMWH Therapy to Skin Change	No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy	Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy	Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy	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.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Duration From Start of UFH/LMWH Therapy to HIT		4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With and Without Complications Under Fondaparinux Therapy	A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator).	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With Thromboembolisms Under Fondaparinux Therapy	Any sign of thromboembolism as indicated by investigator was measured.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With Bleedings Under Fondaparinux Therapy	No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With Skin Changes Under Fondaparinux Therapy	No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy	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.	4 months (all cases occurred between 2004 and 2010)	Yes
Secondary	Duration From Start of Fondaparinux Therapy to HIT	For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented.	4 months (all cases occurred between 2004 and 2010)	Yes