Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery

NCT04517461 | Completed

• 1 other identifier: 2020-00718
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. tissue transferred from for instance the arm or leg to the resection site. Complications of this complex procedure include, but are not limited to, bleeding and blood cloths (thrombosis) in the transferred tissue (free flap), which can cause very serious complications including need for further surgery and loss of the flap. Routine blood tests can measure parts of the system that regulates bleeding and the forming of blood clots, the so called coagulation system, but these tests don't cover the whole system. There are however more advanced instruments, such as ROTEM, rotational thromboelastometry, which provide a more global view of the hemostatic potential of whole blood. ROTEM is one of few more advanced assays that can be analyzed in emergency situations in major hospitals. Other more advanced coagulation assays are thrombin generation and measurements of specific coagulation factors, several of which are vitamin K dependent. Vitamin K is essential in the coagulation system and also involved in many other physiological processes. Deficiency of this vitamin is common, but not well studied in patients undergoing head an neck free flap surgery. The investigators plan to study ROTEM and other above mentioned coagulation parameters in patients undergoing major head and neck surgery including microvascular free flap reconstruction to assess if these parameters can help predict patients at risk for bleeding or flap thrombosis. Further on this could hopefully enable prevention of complications and improve treatment of coagulation complications that still occur.

Conditions

Head and Neck Cancer; Intraoperative Complications; Coagulation Disorder, Blood; Vitamin K Deficiency; Thrombosis; Anticoagulants and Bleeding Disorders; Head and Neck Procedural Complication

Outcome Measures

Primary Outcomes (1)

• Perioperative changes in ROTEM MCF EXTEM

  Perioperative changes in ROTEM MCF (EXTEM). Baseline values measured at start of surgery (day 0), thereafter repeated measurements are made until day 6. Power calculation is based on an expected change in ROTEM MCF (EXTEM) from day 0 to postoperative day 2 (based on Lison et al, Blood Coagul Fibrinolysis. 2011.).

  Day 0 to day 6

Secondary Outcomes (23)

• Perioperative changes in ROTEM Clotting time

  Day 0 to day 6

• Perioperative changes in ROTEM Clot Formation Time

  Day 0 to day 6

• Perioperative changes in ROTEM alpha angle

  Day 0 to day 6

• Perioperative changes in ROTEM Lysis Index 60

  Day 0 to day 6

• Perioperative changes in ROTEM Maximum Clot Firmness

  Day 0 to day 6

Study Arms (1)

Head and neck free flap surgery patients

Patients undergoing head and neck microvascular free flap surgery at Skåne University Hospital, Lund, Sweden.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients that present at, or are referred to, the Department of Otorhinolaryngology - Head and Neck Surgery at Skåne University Hospital in Lund with conditions requiring head and neck surgery including resection and reconstruction with a microvascular free flap. This includes patients from the entire southern health care region, "Södra sjukvårdsregionen".

You may qualify if:

• Patients undergoing head and neck surgery including resection and reconstruction with a microvascular free flap at Skåne University Hospital in Lund, Sweden, who accept participation in the study.

You may not qualify if:

• Age under 18 years.
• Inability to understand information or make an informed choice about participation.
• Hospitalization \> 24 h prior to primary surgery.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Region Skåne

Lund, Skåne County, Sweden

Location

Related Publications (7)

• Cervenka B, Bewley AF. Free flap monitoring: a review of the recent literature. Curr Opin Otolaryngol Head Neck Surg. 2015 Oct;23(5):393-8. doi: 10.1097/MOO.0000000000000189.

  PMID: 26339970 BACKGROUND

• Copelli C, Tewfik K, Cassano L, Pederneschi N, Catanzaro S, Manfuso A, Cocchi R. Management of free flap failure in head and neck surgery. Acta Otorhinolaryngol Ital. 2017 Oct;37(5):387-392. doi: 10.14639/0392-100X-1376.

  PMID: 29165433 BACKGROUND

• Kolbenschlag J, Daigeler A, Lauer S, Wittenberg G, Fischer S, Kapalschinski N, Lehnhardt M, Goertz O. Can rotational thromboelastometry predict thrombotic complications in reconstructive microsurgery? Microsurgery. 2014 May;34(4):253-60. doi: 10.1002/micr.22199. Epub 2013 Oct 21.

  PMID: 24142816 BACKGROUND

• Lison S, Weiss G, Spannagl M, Heindl B. Postoperative changes in procoagulant factors after major surgery. Blood Coagul Fibrinolysis. 2011 Apr;22(3):190-6. doi: 10.1097/MBC.0b013e328343f7be.

  PMID: 21245747 BACKGROUND

• Handschel J, Burghardt S, Naujoks C, Kubler NR, Giers G. Parameters predicting complications in flap surgery. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 May;115(5):589-94. doi: 10.1016/j.oooo.2012.09.007. Epub 2012 Dec 12.

  PMID: 23246227 BACKGROUND

• Kolbenschlag J, Diehm Y, Daigeler A, Kampa D, Fischer S, Kapalschinski N, Goertz O, Lehnhardt M. Insufficient fibrinogen response following free flap surgery is associated with bleeding complications. GMS Interdiscip Plast Reconstr Surg DGPW. 2016 Nov 22;5:Doc22. doi: 10.3205/iprs000101. eCollection 2016.

  PMID: 27975041 BACKGROUND

• Zhou W, Zhang WB, Yu Y, Wang Y, Mao C, Guo CB, Yu GY, Peng X. Are antithrombotic agents necessary for head and neck microvascular surgery? Int J Oral Maxillofac Surg. 2019 Jul;48(7):869-874. doi: 10.1016/j.ijom.2018.10.022. Epub 2018 Nov 26.

  PMID: 30497789 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood. Blood plasma.

MeSH Terms

Conditions

Head and Neck Neoplasms; Intraoperative Complications; Blood Coagulation Disorders; Vitamin K Deficiency; Thrombosis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Caroline U Nilsson, MD, PhD

  Skane University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: August 18, 2020
• Study Start: September 15, 2020
• Primary Completion: September 15, 2021
• Study Completion: October 1, 2021
• Last Updated: February 29, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)