Trial Outcomes & Findings for Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer (NCT NCT00381888)

NCT ID: NCT00381888

Last Updated: 2017-12-28

Results Overview

Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: Week 4 (Days 28-35)
• Results posted on: 2017-12-28

Participant Flow

Participant milestones

Measure	Patients Enrolled and Consented This number includes all patients consented and enrolled in this study.
Overall Study STARTED	44
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Patients Enrolled and Consented This number includes all patients consented and enrolled in this study.
Overall Study Death	1
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1
Overall Study Protocol Violation	9
Overall Study Had laparoscopic surgery	2
Overall Study Surgery was cancelled	2
Overall Study Adverse Event	1

Baseline Characteristics

Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer

Baseline characteristics by cohort

Measure	Patients Enrolled and Consented n=44 Participants This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	55.7 Years n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4 (Days 28-35)

Population: The number includes those patients who completed the study and are evaluable for this outcome measure.

Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.

Outcome measures

Measure	Fondaparinux Patients Who Completed Study n=27 Participants This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
Number of Patients With Venous Thromboembolism at Week 4	0 Participants

SECONDARY outcome

Timeframe: Week 4

Population: These patients completed the study and are considered evaluable for this outcome measure.

This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.

Outcome measures

Measure	Fondaparinux Patients Who Completed Study n=27 Participants This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.	27 Participants

Adverse Events

All Patients Who Received at Least One Dose of Fondaparinux

Serious events: 7 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Patients Who Received at Least One Dose of Fondaparinux n=33 participants at risk This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.
Cardiac disorders Cardiac ischemia/infarction	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Infections and infestations Colitis (C. difficile)	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Infections and infestations Infection/Sepsis	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Gastrointestinal disorders Partial small bowel obstruction	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Infections and infestations Port-a-cath infection	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Vascular disorders Pulmonary embolism, post-op	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Gastrointestinal disorders Small bowel obstruction	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Infections and infestations Wound infection	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.

Other adverse events

Measure	All Patients Who Received at Least One Dose of Fondaparinux n=33 participants at risk This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.
Nervous system disorders Anxiety, increased	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Respiratory, thoracic and mediastinal disorders Atelectasis	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Cardiac disorders Bradycardia	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Skin and subcutaneous tissue disorders Bruising	21.2% 7/33 • Number of events 7 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
General disorders Chills	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Nervous system disorders Cold sensation, upper thighs & lower abdomen	3.0% 1/33 • Number of events 2 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Gastrointestinal disorders Decreased appetite (anorexia)	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Gastrointestinal disorders Dehyration	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Gastrointestinal disorders Diarrhea	3.0% 1/33 • Number of events 2 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Renal and urinary disorders Dysuria	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Gastrointestinal disorders Emesis (vomiting)	12.1% 4/33 • Number of events 4 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
General disorders Fever	15.2% 5/33 • Number of events 7 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Gastrointestinal disorders Heartburn (dyspepsia)	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Blood and lymphatic system disorders Hematoma, retroperitoneal	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Metabolism and nutrition disorders Hypokalemia	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Metabolism and nutrition disorders Hypomagnesemia	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Respiratory, thoracic and mediastinal disorders Hypoxia (oxygen desaturation)	9.1% 3/33 • Number of events 3 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Infections and infestations Infection, wound	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Respiratory, thoracic and mediastinal disorders Lung crackles	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Gastrointestinal disorders Nausea	15.2% 5/33 • Number of events 5 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Nervous system disorders Numbness (paresthesia), upper thighs, lower extremity, abdomen	6.1% 2/33 • Number of events 3 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
General disorders Pain, chest	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Respiratory, thoracic and mediastinal disorders Sleep apnea	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
General disorders Sleeplessness	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Cardiac disorders Tachycardia	6.1% 2/33 • Number of events 2 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Infections and infestations Urinary tract infection	9.1% 3/33 • Number of events 3 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Renal and urinary disorders Urine output, low	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Reproductive system and breast disorders Vaginal discharge	3.0% 1/33 • Number of events 2 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Nervous system disorders Vertigo	3.0% 1/33 • Number of events 1 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Skin and subcutaneous tissue disorders Wound, draining	9.1% 3/33 • Number of events 3 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
Skin and subcutaneous tissue disorders Wound, open	12.1% 4/33 • Number of events 5 • 4 Weeks 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.

Additional Information

Levi S. Downs, Jr., M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-626-6628

Email: downs008@umn.edu

Results disclosure agreements

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