Clinical Trial: Postoperative Bleeding Prevention in Massive Bone Tumour Resection

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Postoperative Bleeding Prevention in Massive Bone Tumour Resection: a Multicentric, Randomized, Parallel, Controlled Trial to Assess the Efficacy of Tranexamic Acid Versus

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.


Detailed Summary:
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Current Primary Outcome: Total blood loss (mL) in the postoperative period [ Time Frame: The first postoperative 48h ]

The blood loss will be collected by the drainage system and quantified in mL.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients requiring blood transfusion [ Time Frame: The first postoperative 2 weeks ]
  • Units of blood transfused [ Time Frame: The first postoperative 2 weeks ]
  • Proportion of patients with wound infection [ Time Frame: The first postoperative month ]
  • Proportion of patients with wound dehiscence [ Time Frame: The first postoperative month ]
  • Proportion of patients with reoperation for wound complications [ Time Frame: The first postoperative month ]
  • Deep venous thrombosis [ Time Frame: The first postoperative 2 weeks ]
  • Proportion of patients with seroma [ Time Frame: The first postoperative month ]
  • Postoperative pain related with the surgery [ Time Frame: The first postoperative week ]
  • Tumoral local relapse rate [ Time Frame: The first postoperative month ]
  • Tumoral systemic dissemination rate [ Time Frame: The first postoperative month ]
  • Mortality [ Time Frame: The first postoperative month ]
  • Proportion of patients in which chemotherapy is delayed for wound complications [ Time Frame: The first postoperative month ]
  • Proportion of patients in which radiotherapy is delayed for wound complications. [ Time Frame: The first postoperative month ]
  • Length of hospital stay [ Time Frame: The first postoperative 2 weeks ]


Original Secondary Outcome: Same as current

Information By: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Dates:
Date Received: May 27, 2014
Date Started: March 2013
Date Completion:
Last Updated: September 19, 2016
Last Verified: September 2016