Clinical trial to evaluate blood loss by administering transexamic acid via topical, intravenous, or both in surgically operated patients with osteous or soft tissue sarcomas.

Phase 1

• Conditions: Oncological orthopedic surgery (bone and soft tissue sarcomas in the appendicular skeleton, pelvis and scapular girdle).; MedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: HLTClassification code 10039498Term: Bone sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003214-27-ES
• Lead Sponsor: Irene Barrientos Ruiz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-09
• Last Update Posted: 13 February 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Male or female patients older than 12 years.
2) Patients with a diagnosis of bone sarcoma or soft tissue sarcoma of more than 10 cm in their largest diameter, appendicular skeleton, pelvis and scapular girdle.
3) Planned surgical intervention in our center (La Paz University Hospital) with the intention of conservative surgery of the limb by means of extensive tumor resection and reconstruction if necessary for soft tissue and / or bone.
4) Preoperative hemoglobin (at the pre-anesthetic assessment, maximum 30 days prior to inclusion) of at least 11 g / dL.
5) The patient or his / her legal representative (if applicable) has understood the study procedures and signed the informed consent.
6) If participant between 12 and 17 years old, the patient must give his assent to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
;
1) Male or female patients older than 12 years.
2) Patients with a diagnosis of bone sarcoma or soft tissue sarcoma of more than 10 cm in their largest diameter, appendicular skeleton, pelvis and scapular girdle.
3) Planned surgical intervention in our center (La Paz University Hospital) with the intention of conservative surgery of the limb by means of extensive tumor resection and reconstruction if necessary for soft tissue and / or bone.
4) Preoperative hemoglobin (at the pre-anesthetic assessment, maximum 30 days prior to inclusion) of at least 11 g / dL.
5) The patient or his / her legal representative (if applicable) has understood the study procedures and signed the informed consent.
6) If participant between 12 and 17 years old, the patient must give his assent to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
;
1) Male or female patients older than 12 years.
2) Patients with a diagnosis of bone sarcoma or soft tissue sarcoma of more than 10 cm in their largest diameter, appendicular skeleton, pelvis and scapular girdle.
3) Planned surgical intervention in our center (La Paz University Hospital) with the intention of conservative surgery of the limb by means of extensive tumor resection and reconstruction if necessary for soft tissue and / or bone.
4) Preoperative hemoglobin (at the pre-anesthetic assessment, maximum 30 days prior to inclusion) of at least 11 g / dL.
5) The patient or his / her legal representative (if applicable) has understood the study procedures and signed the informed consent.
6) If participant between 12 and 17 years old, the patient must give his assent to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1) Known allergy or contraindication to ATX
2) Sarcomas with preoperative intention other than conservative surgery of the limb by wide resection (low grade soft tissue sarcomas with marginal intention, sarcomas requiring radical resection / amputation or bone sarcomas intended for extended intralesional resection).
3) Radical (amputation) programmed surgery.
4) The patient has any of the following comorbidities:
- Severe ischemic heart disease (Class III and IV of the New Cork Heart Association)
- Patients with history of valvulopathy.
- Patients with a history of obstructive sleep apnea syndrome
- History of severe COPD (grade III, IV)
- History of seizures
- Severe renal dysfunction (Creatinine greater than 2mg / dl in male and 1.8g / dl in women in preoperative analysis, maximum 30 days prior to inclusion)
- Severe hepatic dysfunction (Child-Pugh grade C)
5) Coagulopathy identified in the preoperative period (maximum 30 days prior to inclusion), at least 1 of the following:
- Platelet count less than 40,000 / mm3
- International normalized ratio (INR) greater than 1.4
- Prolonged thromboplastin time (aPTT): greater than 1.4 times normal.
6) History of arterial or venous thromboembolic disease
7) History of hematopoietic, hemorrhagic and thrombogenic blood dyscrasias.
8) Retinopathy (limitation of the visual field and distortion in the perception of color)
9) Women of childbearing age with a positive urine pregnancy test the day before surgery.
10) Female patients who are breastfeeding
11) Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study
;
1) Known allergy or contraindication to ATX
2) Sarcomas with preoperative intention other than conservative surgery of the limb by wide resection (low grade soft tissue sarcomas with marginal intention, sarcomas requiring radical resection / amputation or bone sarcomas intended for extended intralesional resection).
3) Radical (amputation) programmed surgery.
4) The patient has any of the following comorbidities:
- Severe ischemic heart disease (Class III and IV of the New Cork Heart Association)
- Patients with history of valvulopathy.
- Patients with a history of obstructive sleep apnea syndrome
- History of severe COPD (grade III, IV)
- History of seizures
- Severe renal dysfunction (Creatinine greater than 2mg / dl in male and 1.8g / dl in women in preoperative analysis, maximum 30 days prior to inclusion)
- Severe hepatic dysfunction (Child-Pugh grade C)
5) Coagulopathy identified in the preoperative period (maximum 30 days prior to inclusion), at least 1 of the following:
- Platelet count less than 40,000 / mm3
- International normalized ratio (INR) greater than 1.4
- Prolonged thromboplastin time (aPTT): greater than 1.4 times normal.
6) History of arterial or venous thromboembolic disease
7) History of hematopoietic, hemorrhagic and thrombogenic blood dyscrasias.
8) Retinopathy (limitation of the visual field and distortion in the perception of color)
9) Women of childbearing age with a positive urine pregnancy test the day before surgery.
10) Female patients who are breastfeeding
11) Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study
;
1) Known allergy or contraindication to ATX
2) Sarcomas with preoperative intention other than conservative surgery of the limb by wide resection (low grade soft tissue sarcomas with marginal intention, sarcomas requiring radical resection / amputation or bone sarcomas intended for extended intralesional resection).
3) Radical (amputation) programmed surgery.
4) The patient has any of the following comorbidities:
- Severe ischemic heart disease (Class III and IV of the New Cork Heart Association)
- Patients with history of valvulopathy.
- Patients with a history of obstructive sleep apnea syndrome
- History of severe COPD (grade III, IV)
- History of seizures
- Severe renal dysfunction (Creatinine greater than 2mg / dl in male and 1.8g / dl in women in preoperative analysis, maximum 30 days prior to inclusion)
- Severe hepatic dysfunction (Child-Pugh grade C)
5) Coagulopathy identified in the preoperative period (maximum 30 days prior to inclusion), at least 1 of the following:
- Platelet count less than 40,000 / mm3
- International normalized ratio (INR) greater than 1.4
- Prolonged thromboplastin time (aPTT): greater than 1.4 times normal.
6) History of arterial or venous thromboembolic disease
7) History of hematopoietic, hemorrhagic and thrombogenic blood dyscrasias.
8) Retinopathy (limitation of the visual field and distortion in the perception of color)
9) Women of childbearing age with a positive urine pregnancy test the day before surgery.
10) Female patients who are breastfeeding
11) Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified