Hip Fracture Surgery Timing and Blood Transfusion Risk in Patients on DOACs

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSt. Antonius Hospital

About this trial

This study looks at patients with hip fractures who are taking direct oral anticoagulants (DOACs), a type of blood thinner. In many hospitals, surgery for these patients is delayed because of concerns about bleeding, but waiting longer can also increase risks such as complications and longer hospital stays. The purpose of this study is to find out whether operating within 24 hours is as safe as delaying surgery beyond 24 hours. Specifically, the investigators want to know if early surgery does not lead to a higher need for blood transfusions compared to delayed surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Isolated hip fracture classified as AO/OTA 31A or 31B requiring surgical intervention.

Current DOAC use with the last dose taken ≤24 hours before emergency department (ED) presentation

Disqualifiers

Pathologic or periprosthetic hip fractures.

Fracture sustained >24 hours before ED presentation.

Inter-hospital transfer.

Hematologic disorders (e.g., thalassemia, sickle cell disease, aplastic anemia, myelodysplastic syndromes, leukemia).

Trial population

Study participants will be selected from patients admitted with an isolated hip fracture to one of seven Dutch level 2 trauma centers. All patients are routinely treated according to local hospital protocols, which differ in surgical timing policies for patients on direct oral anticoagulants. This natural variation provides the basis for the study cohorts (\<24h vs \>24h to surgery).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

374 Participants
are grouped into 2 trial groups
Group A: Early surgery
Group B: Delayed surgery

Trial outcomes

Primary outcomes

1

Number of participants receiving a postoperative blood transfusion

Receiving one or more units of packed red blood cells in the postoperative period during hospitalization

Time frame
From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively)

Secondary outcomes

1

Number of participants receiving a preoperative blood transfusion

Any administration of one or more units of packed red blood cells before hip fracture surgery during hospitalization.

Time frame
From emergency department presentation until start of surgery (up to 7 days preoperatively)
2

Number of packed red blood cells administered postoperatively

Total number of packed red blood cell units administered after hip fracture surgery during hospitalization.

Time frame
From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively)
3

Number of packed red blood cells administered preoperatively

Total number of packed red blood cell units administered before hip fracture surgery during hospitalization.

Time frame
From emergency department presentation until start of surgery (up to 7 days preoperatively)
4

Surgical duration in minutes

Time frame
During surgery/procedure

Other outcomes

Sponsors and contacts

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