Clinical trial NCT02153593: Postoperative Bleeding Prevention in Massive Bone Tumour Resection
Official title: Postoperative Bleeding Prevention in Massive Bone Tumour Resection: a Multicentric, Randomized, Parallel, Controlled Trial to Assess the Efficacy of Tranexamic Acid Versus Evicel® and Usual Haemostasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Blood Loss
Bone Tumour
Keywords: Clinical trial
Randomized
Fibrin glue
Tranexamic acid
Blood loss
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Massive bone tumour resection is often associated with important postoperative bleeding. This may determine systemic (anaemia), as well as local complications (wound healing, seroma, haematoma).

The objective of this study is to determine whether the use of topical tranexamic acid or topical Evicel® will reduce the perioperative bleeding comparing it with usual haemostasis.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Musculoskeletal tumor (primary or metastatic, benign or malignant) located in extremities, shoulder girdle or pelvis.
* Massive or bloc tumour resection.
* Patient's consent to participate

Exclusion Criteria:

* Known allergy to ATX
* Allergy or known hypersensitivity to bovine proteins (aprotinin)
* Liposarcomas low grade
* History of thromboembolic disease or prothrombotic conditions:

  * cerebral vascular accident
  * ischemic heart disease
  * deep and / or superficial vein thrombosis
  * pulmonary embolism
  * peripheral arterial vasculopathy
  * thrombogenic arrhythmias (eg: ACxFA)
  * patients with cardiovascular stents
  * prothrombotic alterations in coagulation
* Treatment with contraceptive drugs

Primary outcomes:
measure: Total blood loss (mL) in the postoperative period
timeFrame: The first postoperative 48h
Secondary outcomes:
measure: Proportion of patients requiring blood transfusion
timeFrame: The first postoperative 2 weeks
measure: Units of blood transfused
timeFrame: The first postoperative 2 weeks
measure: Proportion of patients with wound infection
timeFrame: The first postoperative month
measure: Proportion of patients with wound dehiscence
timeFrame: The first postoperative month
measure: Proportion of patients with reoperation for wound complications
timeFrame: The first postoperative month
measure: Deep venous thrombosis
timeFrame: The first postoperative 2 weeks
measure: Proportion of patients with seroma
timeFrame: The first postoperative month
measure: Postoperative pain related with the surgery
timeFrame: The first postoperative week
measure: Tumoral local relapse rate
timeFrame: The first postoperative month
measure: Tumoral systemic dissemination rate
timeFrame: The first postoperative month
measure: Mortality
timeFrame: The first postoperative month
measure: Proportion of patients in which chemotherapy is delayed for wound complications
timeFrame: The first postoperative month
measure: Proportion of patients in which radiotherapy is delayed for wound complications.
timeFrame: The first postoperative month
measure: Length of hospital stay
timeFrame: The first postoperative 2 weeks
Other outcomes:
Locations:
city: Barakaldo,
country: Spain
facility: Hospital Universitario de Cruces
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital Universitario de San Juan de Alicante
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Ana Peiró, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ibáñez AP, Martinez-Zapata MJ, Tarragó LT, Balaguer MB, Roig XA, Joy IG, Areizaga L, Merino J, Alcalá R, Tranextum Study Group. Postoperative bleeding prevention in massive bone tumour resection: a multicentric, randomized, parallel, controlled trial to assess the efficacy of tranexamic acid versus Evicel and usual haemostasis [protocol]. Basic and Clinical Pharmacology. 2014; 115 (Suppl 3): 20-21.