Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur

NCT03407573 | Completed DMC

• 1 other identifier: WKRO-2016-0018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator wishes to see if it is possible to undertake a study comparing blood transfusion at two different levels of anaemia to see which is best for patients. All patients that present to hospital with a broken hip will be able to take part in the study. If they become anaemic during their treatment they will be allocated to either be transfused when their blood count is less that 9 or less than 7. In all patients, we will measure heart damage with a blood test that is very sensitive. The investigator will also collect data on the incidence of heart attacks and other complications.

Conditions

Anemia; Cardiac Event; Kidney Injury; Fractured Hip

Outcome Measures

Primary Outcomes (1)

• Myocardial Injury

  Myocardial injury defined as a high sensitivity cardiac Troponin 1 (Troponin) concentration above the upper reference limit \[URL\] OF 16 ng L and 34 ng L in women and men respectively at any time during the study period.

  Upto 60 days

Secondary Outcomes (6)

• Myocardial Infarction

  within 30 days of surgery

• Mortality

  upto 60 days following surgery

• Diagnosis of Major Adverse Cardiac Events

  within 30 days or before hospital discharge

• Acute Kidney Injury

  within 30 days of surgery or before discharge from hospital whichever occurs first.

• Infections

  within 30 days of surgery or before hospital discharge, whichever is first.

Other Outcomes (11)

• Troponin

  within 7 days of surgery (ngL )

• Troponin -Time

  within 7 days of surgery

• Red cells transfused

  within7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.

Study Arms (2)

Restrictive

ACTIVE COMPARATOR

Restrictive transfused when Hb at or below 70

Biological: Administration of Red Cell

Liberal

ACTIVE COMPARATOR

Will receive blood transfusion when Hb drops below or equal to 90

Biological: Administration of Red Cell

Interventions

Administration of Red Cell BIOLOGICAL

Transfusion of red cells dependent on haemoglobin level. Either transfused at haemoglobin of 7 or 9.

Liberal; Restrictive

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Refusal of consent of patient (or consultee) Patient for palliative care.

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

Royal Hospital for Sick Children

Edinburgh, United Kingdom

Location

Related Publications (7)

• Acheson AG, Brookes MJ, Spahn DR. Effects of allogeneic red blood cell transfusions on clinical outcomes in patients undergoing colorectal cancer surgery: a systematic review and meta-analysis. Ann Surg. 2012 Aug;256(2):235-44. doi: 10.1097/SLA.0b013e31825b35d5.

  PMID: 22791100 BACKGROUND

• Fowler AJ, Ahmad T, Phull MK, Allard S, Gillies MA, Pearse RM. Meta-analysis of the association between preoperative anaemia and mortality after surgery. Br J Surg. 2015 Oct;102(11):1314-24. doi: 10.1002/bjs.9861.

  PMID: 26349842 RESULT

• Davenport DL, Bowe EA, Henderson WG, Khuri SF, Mentzer RM Jr. National Surgical Quality Improvement Program (NSQIP) risk factors can be used to validate American Society of Anesthesiologists Physical Status Classification (ASA PS) levels. Ann Surg. 2006 May;243(5):636-41; discussion 641-4. doi: 10.1097/01.sla.0000216508.95556.cc.

  PMID: 16632998 RESULT

• Holst LB, Petersen MW, Haase N, Perner A, Wetterslev J. Restrictive versus liberal transfusion strategy for red blood cell transfusion: systematic review of randomised trials with meta-analysis and trial sequential analysis. BMJ. 2015 Mar 24;350:h1354. doi: 10.1136/bmj.h1354.

  PMID: 25805204 RESULT

• Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

  PMID: 41114449 DERIVED

• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

  PMID: 34932836 DERIVED

• Gillies MA, Ghaffar S, Moppett IK, Docherty AB, Clarke S, Rea N, Stephen J, Keerie C, Ray DC, White TO, MacLullich AMJ, Mills NM, Rowley MR, Murthy K, Pearse RM, Stanworth SJ, Walsh TS. A restrictive versus liberal transfusion strategy to prevent myocardial injury in patients undergoing surgery for fractured neck of femur: a feasibility randomised trial (RESULT-NOF). Br J Anaesth. 2021 Jan;126(1):77-86. doi: 10.1016/j.bja.2020.06.048. Epub 2020 Jul 21.

  PMID: 32703548 DERIVED

MeSH Terms

Conditions

Anemia; Cardiovascular Diseases; Hip Fractures

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Dr.Mike Gillies

  Associate Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: January 23, 2018
• Study Start: October 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 11, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)