ThromboembolismFondaPPPNCT01004939
Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism
An observational study of Thromboembolism and Venous Thromboembolism, run by GlaxoSmithKline at 7 sites in Germany.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Thromboembolism, Venous Thromboembolism
- What is being tested?
- fondaparinux
- How many people
- 120 participants
- Where
- 7 sitesGermany
- Study dates
- Mar 2010to Jul 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patients who were treated with fondaparinux for less than 7 days
- Patient who were treated with fondaparinux only postpartum
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
GSK Investigational Site
Berlin, State of Berlin, 13353
GSK Investigational Site
Bonn, Rhineland-Palatinate, 53115
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47051
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Leipzig, Saxony, 04289
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Münster, North Rhine-Westphalia, 48143
About this study
Official title: Retrospektive Studie zu Patientinnen, Die pränatal, Perinatal Oder Postnatal Prophylaktisch Oder Therapeutisch Mit Fondaparinux Behandelt Wurden
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.
Read the 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.
- Conditions
- Thromboembolism, Venous Thromboembolism
- Being tested
- fondaparinux
- Keywords
- prophylaxis, venous thromboembolism, postpartum, fondaparinux, pregnancy
- Medical subject headings
- Thromboembolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fondaparinuxDrug
fondaparinux
| Study group | Role | What they receive |
|---|---|---|
| fondaparinux prescribed subjects | fondaparinux prescribed subjets Receives: Drug: fondaparinux |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
Measured: 4 months (all cases occurred between 2004 and 2010)
Duration of Fondaparinux Administration
Measured: 4 months (all cases occurred between 2004 and 2010)
Duration of Prenatal Fondaparinux Administration
The prenatal interval is defined as the interval of time until 3 days before birth.
Measured: 4 months (all cases occurred between 2004 and 2010)
Duration of Postnatal Fondaparinux Administration
The postnatal interval is defined as the interval of time beginning 2 days after birth.
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Hours After Birth at Which Fondaparinux Administration Was Restarted
Measured: 4 months (all cases occurred between 2004 and 2010)
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With the Indicated Type of Conception/Fertilization
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Participants Who Delivered a Single Child Versus Twins
Measured: 4 months (all cases occurred between 2004 and 2010)
Mean Weight of Newborn
Measured: 4 months (all cases occurred between 2004 and 2010)
Mean Height of Newborn
Measured: 4 months (all cases occurred between 2004 and 2010)
Mean Head Circumference of Newborn
Measured: 4 months (all cases occurred between 2004 and 2010)
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Newborns Who Had a "Healthy" Postnatal Classification
A "healthy" documentation was based on the investigators' individual assessment.
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Newborns With Abnormalities
No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment.
Measured: 4 months (all cases occurred between 2004 and 2010)
Secondary outcomes (18)
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration
Measured: 4 months (all cases occurred between 2004 and 2010)
Duration of Hospitalizations Before, During, and After Fondaparinux Administration
Measured: 4 months (all cases occurred between 2004 and 2010)
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).
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Thromboembolisms Under UFH/LMWH Therapy
Any sign of thromboembolism as indicated by investigator was measured.
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Bleedings Under UFH/LMWH Therapy
No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.
Measured: 4 months (all cases occurred between 2004 and 2010)
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
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.
Measured: 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
Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins.
Measured: 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
Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins.
Measured: 4 months (all cases occurred between 2004 and 2010)
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
Duration From Start of UFH/LMWH Therapy to HIT
Measured: 4 months (all cases occurred between 2004 and 2010)
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).
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Thromboembolisms Under Fondaparinux Therapy
Any sign of thromboembolism as indicated by investigator was measured.
Measured: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Bleedings Under Fondaparinux Therapy
No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.
Measured: 4 months (all cases occurred between 2004 and 2010)
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
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.
Measured: 4 months (all cases occurred between 2004 and 2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004939
- Sponsor's protocol ID
- 112937
- Acronym
- FondaPPP
- Status last verified
- Jul 2011
- First submitted
- 1 Oct 2009
- Last updated
- 26 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 33942675
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospektive Studie zu Patientinnen, Die pränatal, Perinatal Oder Postnatal Prophylaktisch Oder Therapeutisch Mit Fondaparinux Behandelt Wurden
- ClinicalTrials.gov ID
- NCT01004939
- Acronym / sponsor ID
- FondaPPP / 112937
- Conditions
- Thromboembolism, Venous Thromboembolism
- Keywords
- prophylaxis, venous thromboembolism, postpartum, fondaparinux, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Posted 26 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fondaparinux prescribed subjects | – | Drug: fondaparinuxfondaparinux prescribed subjets |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients who were treated with fondaparinux for less than 7 days
- Patient who were treated with fondaparinux only postpartum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fondaparinuxfondaparinux | Drug | fondaparinux prescribed subjects |
Primary outcome
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.
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.
Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
Time frame: 4 months (all cases occurred between 2004 and 2010)
Duration of Fondaparinux Administration
Time frame: 4 months (all cases occurred between 2004 and 2010)
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.
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.
Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Hours After Birth at Which Fondaparinux Administration Was Restarted
Time frame: 4 months (all cases occurred between 2004 and 2010)
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.
Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With the Indicated Type of Conception/Fertilization
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants Who Delivered a Single Child Versus Twins
Time frame: 4 months (all cases occurred between 2004 and 2010)
Mean Weight of Newborn
Time frame: 4 months (all cases occurred between 2004 and 2010)
Mean Height of Newborn
Time frame: 4 months (all cases occurred between 2004 and 2010)
Mean Head Circumference of Newborn
Time frame: 4 months (all cases occurred between 2004 and 2010)
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.
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.
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.
18 secondary outcomes
Number of Participants Hospitalized Because of Thromboembolic Treatment
Time frame: 4 months (all cases occurred between 2004 and 2010)
Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration
Time frame: 4 months (all cases occurred between 2004 and 2010)
Duration of Hospitalizations Before, During, and After Fondaparinux Administration
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Complications Under UFH/LMWH Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Thromboembolisms Under UFH/LMWH Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Bleedings Under UFH/LMWH Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Skin Changes Under UFH/LMWH Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Duration From Start of UFH/LMWH Therapy to Skin Change
Time frame: 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
Time frame: 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
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Duration From Start of UFH/LMWH Therapy to HIT
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With and Without Complications Under Fondaparinux Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Thromboembolisms Under Fondaparinux Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Bleedings Under Fondaparinux Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Skin Changes Under Fondaparinux Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy
Time frame: 4 months (all cases occurred between 2004 and 2010)
Duration From Start of Fondaparinux Therapy to HIT
Time frame: 4 months (all cases occurred between 2004 and 2010)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33942675Dempfle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism and Venous Thromboembolism, run by GlaxoSmithKline at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals (time frame: 4 months (all cases occurred between 2004 and 2010)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01004939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2011.