Trial Outcomes & Findings for Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy (NCT NCT00539942)

NCT ID: NCT00539942

Last Updated: 2017-03-27

Results Overview

Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 7 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2017-03-27

Participant Flow

Patients were recruited from the UAB Gynecologic Oncology Practice from 4/2007 to 6/2010

Difficulty with recruiting subjects to this trial (subjects were not interested in participating)

Participant milestones

Measure	Intermittent Compression Devices Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.	Arixtra (Fondaparinux Sodium) Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy

Baseline characteristics by cohort

Measure	Intermittent Compression Devices n=4 Participants Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.	Fondaparinux (Arixtra) n=3 Participants Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	52 years STANDARD_DEVIATION 12 • n=5 Participants	57 years STANDARD_DEVIATION 7 • n=7 Participants	54 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled.

Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.

Outcome measures

Measure	Intermittent Compression Devices n=4 Participants Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.	Arixtra (Fondaparinux Sodium) n=3 Participants Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra	4 participants	3 participants

SECONDARY outcome

Timeframe: 21 days

Population: Unable to analyze data.

Adverse events will be evaluated to determine untoward effects.

Outcome measures

Measure	Intermittent Compression Devices n=4 Participants Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.	Arixtra (Fondaparinux Sodium) n=3 Participants Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
Incidence of Untoward Effects With Arixtra	0 participants	0 participants

Adverse Events

Intermittent Compression Devices

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

Arixtra (Fondaparinux Sodium)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intermittent Compression Devices n=4 participants at risk Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.	Arixtra (Fondaparinux Sodium) n=3 participants at risk Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
Reproductive system and breast disorders Pelvic Abscess	25.0% 1/4 • Number of events 1 • 21 days	0.00% 0/3 • 21 days
Gastrointestinal disorders Postoperative Ileus	25.0% 1/4 • Number of events 1 • 21 days	0.00% 0/3 • 21 days
Surgical and medical procedures Postoperative Death	25.0% 1/4 • Number of events 1 • 21 days	0.00% 0/3 • 21 days
Infections and infestations Wound infection	0.00% 0/4 • 21 days	33.3% 1/3 • Number of events 1 • 21 days

Other adverse events

Adverse event data not reported

Additional Information

Warner K. Huh, MD

University of Alabama at Birmingham

Phone: 205-996-4662

Email: warner.huh@ccc.uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60