Heart and Blood Diseases

All Conditions

Symptoms and General Pathology

Thrombosis

Venous Thrombosis

Postoperative Complications

Embolism

Embolism and Thrombosis

Vascular Diseases

Anticoagulants

All Drugs and Chemicals

Fibrinolytic Agents

Anti-Infective Agents

Amino Acids

PENTA

Fondaparinux

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

All patients will receive intermittent compression devices (ICD's) during the patient's 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.

Patients randomized to treatment arm will initiate Arixtra (fondaparinux sodium) 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 time and after hospital discharge).

Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.

Arixtra (fondaparinux sodium)

Intermittent compression devices (ICD)

Warner K. Huh, M.D.

This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.

To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

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

Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra (Fondaparinux Sodium): A Randomized Controlled Trial

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

Adverse events will be evaluated to determine untoward effects.

GlaxoSmithKline

University of Alabama at Birmingham

Principal Investigator

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.

Intermittent Compression Devices

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)

Arixtra (Fondaparinux Sodium)

Fondaparinux (Arixtra)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

This trial was terminated early due to poor enrollment and recruitment and the very small number of subjects analyzed. As such, the data is uninterpretable.

Warner K. Huh, MD

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.

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)

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

Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra

Incidence of Untoward Effects With Arixtra

Overall Study

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Cervical Intraepithelial Neoplasia

Pharmaceutical Solutions

Coagulants

Hemostatics

Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.

Haemostasis at the end of the procedure using only Monsel's solution.

This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique

Vaginal Packing

Ricardo D Reis, MD

The LEEP conization is commonly used for cervical pathologies treatment. The techniques for hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is no consensus about the best technique and there is not much information that validates the use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after LEEP conization for management of cervical lesions.

A randomized clinical trial was conducted at Gynecology Oncology Department/Barretos Cancer Hospital for patients with indication of LEEP conization. After local IRB approval, patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2). The Monsel's solution was used in all patients. Intraoperative and postoperative outcomes will be evaluated: operative time, intraoperative and postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as well as short-term outcome were recorded and compared using Chi-square test, Fisher exact test and t-test where appropriate.

Patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2).Randomization was generated through a computer program creating a random entry list in the study, separating in group 1 (local application of Monsel's solution without intra-vaginal gauze buffer) and group 2 (application of Monsel's solution with intra-vaginal gauze). In this way, all patients had an equal chance of being included in both groups.

The allocation of patients to one group or another was only known moments before the surgical procedure was started.

Comparing Two Techniques of Haemostasis After Cervical Conization

Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery

Bleeding was assessed by the need for reintervention.

Barretos Cancer Hospital

Medical Doctor

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

patients aged 65 years old or older : no intervention

patients aged 18-64 years (added by amendment n°3 -02/2014) : no intervention

No intervention

Background: Inadequate representation of elderly cancer patients in randomized clinical trials (RCTs) leading to a lack of external validity thereby an uncertainty regarding benefit-risk balance of cancer treatment in elderly, especially chemotherapy.

Hypothesis: The eligibility criteria explain only a part of the under-representation of elderly patients in trials. We make the assumptions that 1) Among the eligible, the invitation to participate in a trial and inclusion are inversely related to age, 2) Among the eligible, there are patients, practitioner, or organization factors that would explain the non inclusion of elderly patients.

Objectives:

1) To assess, in elderly patients with colorectal cancer, the proportions of patients:

1. eligible at least to one RCT
2. invited to participate
3. included 2)

a) Compare proportions among elderly patients to those of the comparator group of "young" subjects (age ≥ 18 and \<65 years) (added by amendment n°3 accepted 18/02/2014) b)To identify factors associated with the non-invitation and the non-inclusion in RCT.

Material and methods:

Study design: A multicentric prospective cohort survey Population: all patients aged 18 years or more (added by amendment n°3 - 02/2014) with a colorectal cancer followed in one of the participating centers.

Data collection:

* At baseline: Patient characteristics (including SOCIO-demographic, oncologic and geriatric data) will be collected. Organization factors (e.g. clinical research team) will be collected.
* Follow-up: the patient will be followed for potential invitation and inclusion in one RCT. Reasons of non-invitation or non-inclusion will be assessed.

Number of subjects needed: 696 (553 elderly patients and 143 "young" patients) Number of centers : 7 (added by amendment n°3 - 02/2014)

Ethical aspects: each patient will give his oral informed consent. The International Review Board of Mondor Hospital (CPP Ile-de-France IX) gave its approval in December 2012.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy	NCT00539942	Venous Thrombos...	Arixtra (fondap... Intermittent co...	19 Years - 85 Years	University of Alabama at Birmingham
Comparing Two Techniques of Haemostasis After Cervical Conization	NCT03293628	Cervical Intrae... Cervix Neoplasm	Vaginal Packing	19 Years - 68 Years	Barretos Cancer Hospital
Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials	NCT01754636	Colorectal Canc...	No intervention	18 Years -	Assistance Publique - Hôpitaux de Paris
Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials	NCT01754636	Colorectal Canc...	No intervention	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for randomized clinical trials